WO2007138598A2 - Stimulation et réhabilitation du cerveau - Google Patents

Stimulation et réhabilitation du cerveau Download PDF

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Publication number
WO2007138598A2
WO2007138598A2 PCT/IL2007/000664 IL2007000664W WO2007138598A2 WO 2007138598 A2 WO2007138598 A2 WO 2007138598A2 IL 2007000664 W IL2007000664 W IL 2007000664W WO 2007138598 A2 WO2007138598 A2 WO 2007138598A2
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WO
WIPO (PCT)
Prior art keywords
optionally
stimulation
brain
patient
exemplary embodiment
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PCT/IL2007/000664
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English (en)
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WO2007138598A3 (fr
Inventor
Omer Einav
Haim Einav
Ernesto Korenman
Samuel Faran
Sagit Betser
Anna Oyzerman
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Tylerton International Inc.
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Publication date
Application filed by Tylerton International Inc. filed Critical Tylerton International Inc.
Publication of WO2007138598A2 publication Critical patent/WO2007138598A2/fr
Publication of WO2007138598A3 publication Critical patent/WO2007138598A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14553—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted for cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A61B5/377—Electroencephalography [EEG] using evoked responses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A61B5/395—Details of stimulation, e.g. nerve stimulation to elicit EMG response
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4058—Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
    • A61B5/4064—Evaluating the brain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/486—Bio-feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/70—Means for positioning the patient in relation to the detecting, measuring or recording means
    • A61B5/702—Posture restraints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0484—Garment electrodes worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/20—Applying electric currents by contact electrodes continuous direct currents
    • A61N1/205—Applying electric currents by contact electrodes continuous direct currents for promoting a biological process
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/242—Detecting biomagnetic fields, e.g. magnetic fields produced by bioelectric currents
    • A61B5/245—Detecting biomagnetic fields, e.g. magnetic fields produced by bioelectric currents specially adapted for magnetoencephalographic [MEG] signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition

Definitions

  • the present invention relates to stimulating the brain, for example, as part of a rehabilitation process.
  • Northstar Inc. a USA company, sells implantable stimulators for use in conjunction with rehabilitation.
  • Implantable brain stimulators the disclosures of which are incorporated herein by reference: WO06053143A2, WO06053114A2, WO06019766A2, WO06019764A2, WO05068012A1, WO05011805A2, WO05002665A2, WO05002664A2, WO05000153A2, WO04066820A2, WO04052183A2, WO04058347A1, WO04052449A1, WO04052448A1, WO04050175A1, WO04036765A2 and WO03082402A2.
  • Hummel et al. ( Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke(2005)Brain 128:480-499; fully incorporated herein by reference) describes a double blind, Sham-controlled, crossover study conducted to test the hypothesis that non-invasive stimulation of the motor cortex could improve motor function in the paretic hand of patients with chronic stroke.
  • Hand function was measured using the Jebsen-Taylor Hand Function Test (JTT). JTT measured in the paretic hand improved significantly with non-invasive transcranial direct current stimulation (tDCS), but not with Sham. The effect persisted after the stimulation period in all patients tested and correlated with an increment in motor cortical excitability within the affected hemisphere, expressed as increased recruitment curves (RC) and reduced short-interval intracortical inhibition.
  • JTT Jebsen-Taylor Hand Function Test
  • Hesse et al (Combined transcranial direct current stimulation and robot assisted arm training in subacute stroke patients: A pilot study (2007) Restorative Neurology and Neurosciences 25: 9-15; fully incorporated herein by reference) describe a use of transcranial direct stimulation (tDCS) with robot-assisted arm training (AT) 5 to inform planning a larger randomized controlled trial.
  • Subjects received thirty 20 min-sessions of AT over six weeks. During the first 7 minutes, 1.5mA of tDCS was applied, with the anode over the lesioned hemisphere and the cathode above the contralateral orbit.
  • US 5,377,100 describes neurofeedback devices in which brain electrical activity is measured to determine levels of awareness and the difficulty level of the game is increased as the awareness level value decreases and is decreased as this awareness level value increases.
  • US 6,450,820 describes apparatus and methods for modulating control function of a computer simulation or game input device using physiological information so as to affect the user's ability to impact or control the simulation or game with the input device. Control modulation can be used along with a computer simulation or game, to affect physiological state or physiological self-regulation according to some programmed criterion (e.g., increase, decrease, or maintain) in order to perform better at the game task.
  • some programmed criterion e.g., increase, decrease, or maintain
  • NIRS Near-infrared spectroscopy
  • NIRS can be calculated.
  • NIRS employs an array of sensors each operating at multiple wavelengths to produce a map of oxygen saturation in an area in which the sensors are deployed.
  • NIRS sensors can be applied with less skin preparation than standard EEG electrodes.
  • Northstar Inc. has published plans for a feasibility study to evaluate an implanted cortical stimulation device (CSD): (wwwDOTnorthstarneuroDOTconi/clinicaltrials/patient aphasia.asp; fully incorporated herein by reference) with regard to its safety and effectiveness in improving the speech of chronic stroke patients with Broca's aphasia (inability to speak or to organize muscular movements of speech).
  • CSD cortical stimulation device
  • the experimental group will undergo surgery to implant the CSD and then undergo a speech-language therapy program.
  • the CSD is activated only during the speech-language therapy sessions at a level not felt by the patients.
  • the CSD is to be removed approximately 2 weeks after the speech-language therapy is complete.
  • a control group will participate in the same speech-language therapy sessions but will not have the CSD implanted. After speech- language rehabilitation is complete, participants from experimental and control groups will return for periodic follow-up visits.
  • an aspect of some embodiments of the invention relates to providing a response to a measured brain activity, wherein the response is designed to control the brain activity.
  • the response can include one or more of guided imagination, cerebral stimulation (e.g. electrical or magnetic), visual image presentation, auditory stimulation, olfactory stimulation and motor stimulation.
  • the response is provided as an adjunct to a therapy program, optionally during performance of therapy tasks or during a therapy session.
  • the therapy program includes one or more of visual presentation (e.g. as a series of images on a display), mechanical manipulation (e.g. by a passively or actively operated mechanical device) and guided imagination (e.g. an instruction to "imagine you are bending your left elbow to bring the palm of your hand to your right shoulder".
  • visual presentation can be of therapy tasks and/or a portion of the response.
  • the visual presentation comprises a video or animation sequence.
  • a controller receives an output signal indicative of the brain activity from a sensor and adjusts an administered therapy task as part of a response to the output signal.
  • the apparatus is used for closed loop rehabilitation, where the input for the control loop comprises one or more of rehabilitation progress, physiological measures (e.g. O 2 saturation of relevant portions of the brain), quality of electrical sensing from brain (e.g. a signal to noise ratio), sensed brain signals and the output comprises changes in one or more of rehabilitation plan, rehabilitation exercise parameters, electrode location for sensing and/or stimulation parameters.
  • physiological measures e.g. O 2 saturation of relevant portions of the brain
  • quality of electrical sensing from brain e.g. a signal to noise ratio
  • sensed brain signals e.g. a signal to noise ratio
  • an output signal from the sensor serves as an input signal for a brain computer interface (BCI) and the administered therapy comprises Transcranial Direct Current Stimulation (tDCS; Nitsche et al. (2003) Suppl. Clin. Neurohysiol. 56:255-276 and Paulus (2003) Suppl. Clin. Neurohysiol. 56:249-254; the contents of which are each fully incorporated herein by reference).
  • the BCI operates in conjunction with a robotic training element (e.g. motorized) to provide a stimulus for brain activity.
  • the BCI provides a biofeedback signal which indicates to the patient what effect on brain activity is sensed.
  • the BCI trains a patient to distinguish (e.g., generate selectively) a desired pattern of brain activity associated with imagination of different simple motor actions, such as right or left hand movements.
  • the patient is trained to regulate and to control their EEG.
  • control of EEG is achieved by implementing an algorithm which evaluates EEG patterns and presents a feedback to the patient in a simpler format (e.g. audible signal and/or presentation of a symbol on a computer screen).
  • a person controls a computer based system using the BCI by changing specific parameters of their brain activity.
  • parameters can include one or more of mu rhythm, CNV and SCP.
  • a persons' brain activity is recorded by EEG electrodes and the BCI software analyses the mu rhythm intensity of the recording.
  • the software sends an electric stimulation signal to the brain to raise the brain activity to the threshold.
  • the software cues the robot to move its arm (attached to the patients' hand) and/or shuts off the stimulation.
  • movement of the robot contributes to a positive feedback to the patient.
  • the positive feedback informs the person that brain activity was successfully changed.
  • a broad aspect of some embodiments of the invention relates to apparatus for stimulating brain tissue in conjunction with rehabilitation, the stimulation being external to the body.
  • the apparatus comprises an ergonomic helmet which is adjustable per patient.
  • at least some parts of the helmet contacting a patient are disposable, for example, electrodes are disposable.
  • an aspect of some embodiments of the invention relates to using a same helmet design which includes electrodes for sensing and/or stimulating means at multiple types of locations.
  • the helmet is used in a plurality of locations selected from: hospital bed, hospital clinic, rehabilitation clinic, neurologist clinic, old age home, community center, home bed, home chair, home computer station and/or home ambulatory use.
  • the helmet is used in at least 3, at least 4, at least 5, or a greater number of these locations.
  • the helmet is ported by a patient and/or while being worn by a patient.
  • the helmet includes means for ensuring that stimulation and/or sensing are applied in a repeatable manner to desired locations on the skull and/or inside the brain.
  • helmet is meant a device attached to and/or mounted on the head, which may be in the form, for example, of a skull cap, cap, hat a full helmet and/or a head band.
  • the helmet can be provided as a detachable module, integrated into a larher therapy apparatus (e.g. attached to a chair, to a bed, fMRI system , to a rehabilitation robot).
  • a larher therapy apparatus e.g. attached to a chair, to a bed, fMRI system , to a rehabilitation robot.
  • helmets are designed in consideration of an intended use location(e.g. a therapy room or the patients home).
  • the helmet is cordless or equipped with a connecting cords sufficiently long to facilitate unfettered motion of a wearer throughout the intended use location.
  • the helmet communicates with an external controller via a port (e.g. USB or blutooth).
  • the external controller is incorporated into a stationary device (e.g. desktop computer) or a portable device (e.g. cellular telephone or personal digital assistant).
  • a portable therapy system is provided to a patient by providing a helmet with brain activity sensors and stimulation electrodes which communicate with a portable controller.
  • the portable controller is attached to or incorporated in the helmet.
  • the helmet is associated with a safety circuit which prevents stimulation in certain cases.
  • stimulation is prevented if sensing is abnormal, if helmet is placed incorrectly and/or if patient is deemed incapable of handling more stimulation and/or rehabilitation.
  • the helmet is associated with a data logger, which logs, for example, data generated by the helmet, patient information sensed by the helmet or by other means, external events and/or information sent from external devices.
  • logging can include logging of one or more of activity events (e.g., related and/or unrelated to rehabilitation), sensed signals, stimulation parameters (optionally including stimulation position), helmet operation, placement accuracy and/or physiological data, such as ECG and/or brain 02 saturation map data.
  • the logging includes logging activity at a home computer, for example, for tracking usage thereof in conjunction with a rehabilitation process.
  • the helmet in ambulatory and/or home use, is associated with a data transmitting and/or instruction receiving unit, for example, a cellular telephone and/or a wireless or wired link to a personal computer.
  • a data transmitting and/or instruction receiving unit for example, a cellular telephone and/or a wireless or wired link to a personal computer.
  • a data transmitting and/or instruction receiving unit for example, a cellular telephone and/or a wireless or wired link to a personal computer.
  • a data transmitting and/or instruction receiving unit for example, a cellular telephone and/or a wireless or wired link to a personal computer.
  • a data transmitting and/or instruction receiving unit for example, a cellular telephone and/or a wireless or wired link to a personal computer.
  • only electrical stimulation is available.
  • no stimulation is available.
  • magnetic or other stimulation is available.
  • the helmet is associated with and controls and/or receives data from one or more body sensors and/or stimulation units, for example, a sensor which measures limb position (or movement thereof) and/or visual stimulation by a computer display or DVD player.
  • the data is sent to a controller separate from the helmet which coordinates the activities/sensing of the helmet and sensors/stimulation units.
  • clinical use by a neurologist is as follows.
  • a patient is set up in a rehabilitation station (e.g., is stationed and a helmet attached to him and/or a rehabilitation system attached to him) and a neurologist sets up stimulation settings and/or applies stimulation.
  • a rehabilitation station e.g., is stationed and a helmet attached to him and/or a rehabilitation system attached to him
  • a neurologist sets up stimulation settings and/or applies stimulation.
  • Monitoring of the patient rehabilitation activity is optionally by computer and/or a nurse.
  • the neurologist may be called to apply a new stimulation and/or assess the effects of a previously applied stimulation.
  • the helmet can control internal (to the person) stimulation electrodes.
  • the helmet sends a control signal to a control box that is inside or outside the patient's body, which box powers and/or controls the stimulation electrodes.
  • the signal may, for example, set stimulation parameters, trigger stimulation, prevent stimulation and/or select which of a plurality of implanted electrodes to stimulate.
  • the helmet includes or is associated with a power transmitter adapted to send power to the implanted electrodes and/or a controller thereof.
  • An aspect of some embodiments of the invention relates to a helmet device with position adjustable electrodes for sensing and a position adjustable stimulation system.
  • the stimulation system comprises magnetic stimulation.
  • the stimulation system comprises electrical stimulation.
  • other stimulation methods for example as known in the art of brain stimulation, may be used.
  • the helmet provides external stimulation which interacts with an implanted stimulation device.
  • the helmet receives control signals from the implanted stimulation device and/or synchronizes the external stimulation to stimulation from the implanted device.
  • the external stimulation interacts with a software module which can control it.
  • control of the external and/or internal stimulation devices can be exercised by a helmet component or an external controller.
  • an external controller can control both implanted and external stimulatiuon devices.
  • this configuration facitates tuning of internaland external stimulation one to the other, and helmet so that you can then tune one or the other.
  • parameters of stimulation protocol e.g. DC pulsatile, bursts or oscillative
  • intensity, duration, phase, period and other characteristics of the signal are determined by the type of the motor exercise (e.g. exercise mode, needed force, duration, range of motion) and/or are adjusted in response to a measure brain activity.
  • determination and/or adjustment of stimulation parameters is made in accord with a table or rule set or database or expert system or software module that matches parameters with type of motor exercise and/or measured brain activity.
  • a table or rule set or database or expert system or software module is customized to an individual patient.
  • the adjustable electrodes are each adjustable in two axes.
  • the axes are perpendicular circumferential axes (e.g., treating the skull as a generalized sphere).
  • the electrodes lock in place once adjusted.
  • the electrodes are adjustable by hand.
  • the electrodes are adjustable using a motor, for example, a motor that is manually controlled and/or under computer control.
  • an adjustable stimulator rides on a joint which supports motion of the stimulator in a surface parallel to the shape of the skull (or an idealization thereof, such as an ovoid).
  • the helmet includes a head band section on which one or more elongate support elements are mounted, for example, 3,
  • An electrode may be selectively positioned on the elongate support element and the support element may be selectively positioned along the head band.
  • the elongate support elements are elastic and are biased to apply pressure on the skull.
  • the head band is adjustable in diameter and/or is flexible, so it can conform to a skull shape.
  • the head-band is plastically deformable by hand, to confirm to the skull shape.
  • the helmet includes an ear electrode adapted to be located at or near an ear, for example, for providing a reference signal.
  • the ear electrode is mounted on an adjustable support element.
  • the head band and/or electrodes and/or support elements are disposable, i.e., they are designed for single use.
  • the helmet includes or is associated with a control box, which is not disposable.
  • the helmet includes a membrane adapted to fit on the skull, for example, in the form of a skull cap, and assist contact of electrodes with the skull.
  • the membrane is conductive through its thickness, and passes electrical signals from the skull to the electrodes.
  • it has a lower conduction along the membrane. This lower conduction may be caused by a narrow thickness thereof.
  • a stimulation element which is selectively positionable relative to the helmet, for example, being mounted on a two axis joint.
  • the helmet is marked with indications of standard stimulation and/or sensing locations.
  • the helmet is marked with patient specific locations, for example, using a permanent marker.
  • the helmet includes one or more sensors, for example, an encoder, which indicates a correct positioning of electrodes relative to the rest of the helmet.
  • the helmet does not operate if the electrode position does not match a preprogrammed electrode position.
  • the helmet detects its position relative to the skull.
  • the position is detected based on measured electrical signals.
  • the position is detected by matching of a detector on the helmet and a marker attached to the patient skull. If such matching fails, the helmet may be in an incorrect position.
  • Two three or more markers can be provided.
  • the marker includes a relative orientation indication (e.g., in the form of a graphic pattern).
  • An aspect of some embodiments of the invention relates to a helmet adapted for structural and/or functional attachment to a rehabilitation system.
  • the helmet is mounted on a rehabilitation system, thus reducing the weight applied to patient head.
  • the helmet has a quick connect coupler for attachment and/or detachment from a rehabilitation system, for example a chair-based system.
  • the helmet is balanced with a counter weight to reduce discomfort.
  • the coupler is adjustable, to match patient size and/or comfort.
  • the helmet includes a circuit that controls the rehabilitation process.
  • the rehabilitation device controls the helmet (e.g., sets electrode sensing properties and/or stimulation properties) and/or uses signals from the helmet as triggers and/or input.
  • the helmet is designed to work also or only in a stand alone mode, in which the element measures and/or stimulates without an external command.
  • the helmet stimulates in response to signals measured by the helmet or under helmet control.
  • one or more articulated arms are used to hold the stimulation element and/or one or more electrodes for selective positioning on the skull.
  • helmet and/or head supports are provided at least for fixation of the patient head and/or marking of positions on the skull.
  • a vacuum connection, snap connection or other type of temporary connection is provided between the electrodes/stimulation element and the helmet. Such fixation may be useful, for example, when the helmet is provided as a rubber skull cap that does not limit patient head motion.
  • the helmet includes at least one helmet electrode in the articulated arm embodiment. This is useful, for example, when the stimulation effect lasts several minutes and the patient is allowed to move his head during rehabilitation.
  • An aspect of some embodiments of the invention relates to a method of improving the accuracy of an external stimulation method, in which feedback and/or exact motion/stimulation of a body part (e.g. a limb or a portion of the mouth/face) are used to fine tune a position and/or focus an effect of stimulation.
  • a body part e.g. a limb or a portion of the mouth/face
  • stimulation at body portions other than the skull, for example, mechanical manipulation of a limb is used to increase sensitivity of the brain to external stimulation via the skull or via direct stimulation.
  • measuring electrical signals from the skull in response to actuator-mediated motions or position sensor measured motions are used to indicate an exact location in the brain where stimulation may be useful and/or useful stimulation parameters.
  • measuring electrical signals from the skull in response to initiated speech or other cognitive activity to indicate an exact location in the brain where stimulation may be useful and/or useful stimulation parameters.
  • measuring an effect of brain stimulation on a motion of a body part are used to better select a desired stimulation point and/or stimulation parameters, and/or an optimal set of stimulating electrodes for each task (out of all the electrodes).
  • exemplary stimulation parameters include, but are not limited to, intensity, duration, period, and protocol type.
  • exemplary protocol types include, but are not limited to, DC, pulsatile and oscillative.
  • motion of the body part can be measured in terms of direction of motion, applied force, tempo of movement, bilateral / unilateral motion, full body exercise vs. single joint.
  • measuring an effect of brain stimulation on a specific cognitive response is used to better select a desired stimulation point and/or stimulation parameters.
  • auditory sensors can be employed to measure the amplitude of the speech response.
  • an iterative process is carried out, whereby electrodes and/or a stimulation element are repositioned and/or their parameter settings changed in response to motion or cognitive activities as measured by position sensors and/or an actuator.
  • the effect of exact/known motion (or other stimulation) of a limb, or the affect of exact cognitive activity on the brain is used to reposition electrodes and/or stimulator and/or set parameters.
  • rehabilitation exercises are selected based on the measurable effects of some types of stimulation on the body and/or ability to measure better the effect of an exercise.
  • An aspect of some embodiments of the invention relates to using an external stimulator and/or sensing array for assisting in using and/or configuring implanted brain electrodes, in conjunction with rehabilitation.
  • one or more external stimulators and one or more implanted brain electrodes are controlled by a common controller.
  • one or more implanted brain electrodes are operated based upon measurements of brain activity, optionally measurements from one or more helmet mounted sensors.
  • An aspect of some embodiments relates to a two tiered therapy process comprising a mapping or evaluation stage and a therapy stage.
  • the mapping or evaluation stage employs a greater number of sensors and/or stimulation electrodes than the therapy stage.
  • the rehabilitation is performed by a person other than said therapist.
  • the rehabilitation is performed by a computerized system which adjusts the tasks in response to the monitoring in order to close a feedback loop.
  • the method includes: producing a rehabilitation progress report.
  • the sensors are external to the patients.
  • at least some of the sensors are implanted in the patients.
  • at least some of the sensors measure a brain activity.
  • at least some of the sensors measure a muscle activity.
  • the tasks are performed with a brain computer interface (BCI).
  • the monitoring comprises computing a brain plasticity index (BPI).
  • the method comprises applying a transcranial direct current stimulation (tDCS).
  • a rehabilitation therapy kit comprising: a body adapted to be coupled to a head and adapted for communication with a therapy module; the therapy module mounted on the body and comprising at least one of:
  • the kit includes at least one peripheral device adapted for communication with a therapy module and adapted to perform at least one function selected from: (i) function as a sensor; and (U) respond to an instruction from a machine on which the instructions of the machine readable media have been installed.
  • the kit includes a logging module adapted to store data pertaining to at least one of: brain activity; signals provided by the at least one stimulator; and a motor response to the signals provided by the at least one stimulator.
  • a treatment apparatus comprising: (a) at least one sensor of brain activity capable of providing an output signal;
  • a presentation module adapted to provide at least one task to a patient
  • a controller adapted to adjust tasks presented by the therapy module in response to the analysis; thereby adjusting the tasks closes a feedback loop.
  • the therapy module comprises a physical therapy component and the tasks comprise exercises of a body part.
  • the apparatus includes a stimulation module adapted to apply electric stimulation to a specific target in a brain.
  • the stimulation module is adapted to apply transcranial direct current stimulation (tDCS).
  • tDCS transcranial direct current stimulation
  • the analysis computes a brain plasticity index (BPI) or an indication of change therein.
  • the output signal operates a brain computer interface (BCI).
  • the tasks comprise imagining a motor activity.
  • the tasks comprise imagining a situation.
  • the tasks comprise motor activities.
  • the apparatus comprises: (e) a logging module adapted to store data pertaining to at least one of:
  • a treatment method comprising:
  • a therapy apparatus comprising: , a plurality of sensors adapted to sense brain activity; a brain computer interface (BCI) adapted to: provide a positive user feedback if the brain activity exceeds a threshold; and provide no positive user feedback if the brain activity does not exceed the threshold; a stimulation module adapted to apply a specified stimulation only if the brain activity does not exceed the threshold.
  • BCI brain computer interface
  • the apparatus is configured so that a user feedback is provided in at least 50%, optionally 75%, optionally 90% of user attempts to produce brain activity which exceeds the threshold.
  • a helmet-like device for rehabilitation comprising: a body adapted to be coupled to a head; at least one external sensor adapted to sense brain activity and mounted on said body; and at least one external stimulator adapted to stimulate a brain and mounted on said body.
  • the device is configured as a portable device or a stationary device.
  • the device comprises circuitry configured to operate said device both when the device is physically attached to a rehabilitation system and when not attached, said operation being different in attached and unattached conditions.
  • the circuitry closes a control loop between stimulation and sensing.
  • the circuitry wirelessly interacts with at least one device not physically attached to said device.
  • the wireless interaction is via a Bluetooth protocol.
  • the device at least one of is controlled by and controls said rehabilitation system, when attached thereto.
  • the at least one external sensor includes a Near-infrared spectroscopy
  • the external stimulator is adapted to provide at least one stimulation type selected from the group consisting of electrical and magnetic.
  • a helmet-like device for rehabilitation comprising: a body adapted to be coupled to a head; at least one external stimulator adapted to stimulate a brain and mounted on said body; and circuitry configured to operate said helmet both when physically attached to a rehabilitation system and when not attached, said operation being different in both attached and unattached conditions.
  • the device is configured as a portable or a stationary device.
  • the device is adapted to connect both mechanically and functionally to said rehabilitation system.
  • the device is adapted to attach to said rehabilitation system using a quick connect attachment.
  • the device is counter balanced when attached to said rehabilitation system.
  • the device is attached in a manner which reduces gravitational strain on a patient's head.
  • a head- worn adjustable electrode device comprising: a body; and a plurality of electrodes attached to said body and selectively positionable relative to a head, when said body is worn on a head, said body being adapted for selective positioning of electrodes.
  • the body comprises a band and comprising a plurality of electrode supports circumferentially arrangable on said band.
  • at least one of the electrode supports is an elongate electrode support defining multiple attachment positions for an electrode thereon.
  • the body is adjustable.
  • the body is plastically deformable.
  • the device comprises at least one brain stimulation device coupled to said body and whose position is adjustable relative to said body.
  • the head is approximated by a sphere, with a hemisphere corresponding to skull areas overlying the brain, said electrodes and said stimulator are selectively positionable substantially anywhere on at least half the surface of said hemisphere.
  • a method of treating a patient comprising: mounting a plurality of brain activity sensors on the patient using a head- worn device; rehabilitating the patient utilizing signals from said sensors, at least at a clinical setting and at a home setting.
  • a same device design is is used in the clinical setting and the home setting.
  • a same device is used in multiple settings over a period of time of at least one week.
  • the mounting comprises mounting at least one Near-infrared spectroscopy (NIRS) sensor.
  • NIRS Near-infrared spectroscopy
  • the method comprises: stimulating the patient during the rehabilitating; and monitoring an influence of the stimulating on the signals and adjusting the stimulating in response to the influence; thereby forming a closed feedback loop.
  • the stimulating comprises applying an electric stimulus.
  • the stimulating comprises applying a motor stimulus.
  • a method of rehabilitation management comprising: providing a plurality of patients ; while said patients are in a same care location, setting brain stimulation parameters for said patients by a therapist; rehabilitating said patients at said care location by a person other than said therapist, not under the direct attention of said therapist; and monitoring said rehabilitation and an effect of stimulation by said therapist.
  • the stimulation is externally applied stimulation.
  • an external head-mounted brain stimulator comprising: at least one sensor input; a stimulator adapted to stimulate a brain; and circuitry which prevents stimulation responsive to signals from said sensor input.
  • the sensor input comprises an EEG input
  • the sensor input comprises a Near-infrared spectroscopy (NIRS) input.
  • the sensor input comprises a positioning indicating input.
  • the sensor input comprises a contact-quality indicating input.
  • a rehabilitation system comprising: at least one articulated arm having a stimulator mounted thereon; a patient support positioned so that a head of a patient can be selectively stimulated at multiple locations using said stimulator; and a helmet adapted for mounting on the patient's head.
  • the helmet includes a plurality of positionable sensing electrodes.
  • the stimulator is selectively attachable to said helmet.
  • the helmet is rigidly attached to said support.
  • a method of enhancing the accuracy of sensing or modifying brain activity comprising: placing in proximity to brain, at a first position, a sensing or stimulating element such that a certain effective brain volume is associated with the element; operating the element; causing measured motion of a body part; analyzing a relationship between said operating and said motion; and selectively moving said element to a new position in proximity to the brain, based on said analyzing.
  • the element is external to the body.
  • the element is internal to the body.
  • a method of rehabilitation of a patient using an external sensing array, a rehabilitation system and an internal stimulator comprising: stimulating a brain of the patient using said internal stimulator; locating an external sensing array in a position where it can sense brain activity; causing activity of said patient using said rehabilitation system; sensing brain activity using said array; and modifying at least one of said stimulating, said causing and a parameter of said sensing in response to at least one of a signal generated by said sensing and an effect of said causing other than on the brain.
  • the method comprises applying external stimulation.
  • the external array comprises a controller which controls said internal stimulator.
  • the external array comprises Near-infrared spectroscopy (NIRS) optical fibers and detector fibers.
  • NIRS Near-infrared spectroscopy
  • a method of determining a correct electrode placement or activation profile comprising: (a) measuring brain activity at a plurality of locations while a subject sequentially: (i) engages in an activity to produce a signal measurement; and (ii) refrains from the activity to produce a noise measurement; (b) processing signal measurements and noise measurements from the plurality of locations to produce signal:noise ratio data; and (c) selecting at least one preferred location characterized by a desired signahnoise ratio for electrode placement.
  • the activity comprises imagining a motor activity.
  • the activity comprises performing a motor activity.
  • the activity is performed with an un-affected body part.
  • the activity is performed with an affected body part corresponding to an unaffected body part.
  • the method comprises placing a stimulation electrode at the at least one preferred location.
  • the method comprises placing a sensor at the at least one preferred location.
  • a method of determining a correct electrode placement or activation profile comprising: (a) measuring brain activity with two sets of sensors, each set characterized by a different resolution, at a plurality of locations while a subject sequentially: (i) engages in an activity to produce a first signal; and (ii) refrains from the activity to produce a second signal;
  • a 8 method of therapy comprising:
  • mapping neural activity in a brain of a patient to determine a disability focus (a) mapping neural activity in a brain of a patient to determine a disability focus; (b) conducting rehabilitation training while monitoring neural activity at the disability focus.
  • a portable helmet-like device for rehabilitation comprising: a body adapted to be coupled to a head; at least one external sensor adapted to sense brain activity and mounted on said body; and at least one external stimulator adapted to stimulate a brain and mounted on said body.
  • the device comprises circuitry configured to operate said device both when the device is physically attached to a rehabilitation system and when not attached, said operation being different in the two conditions.
  • said circuitry closes a control loop between stimulation and sensing.
  • said circuitry wirelessly interacts with at least one device not physically attached to said device.
  • the external stimulator and/or external sensor interact wirelessly with other components (e.g. wireless EEG electrodes).
  • other components e.g. wireless EEG electrodes.
  • a Bluetooth wireless communication protocol is implemented.
  • said device at least one of is controlled by and/or controls said rehabilitation system, when attached thereto.
  • a portable helmet-like device for rehabilitation comprising: a body adapted to be coupled to a head; at least one external stimulator adapted to stimulate a brain and mounted on said body; and circuitry configured to operate said helmet both when physically attached to a rehabilitation system and when not attached, said operation being different in the two conditions.
  • said device is adapted to connect both mechanically and functionally to said rehabilitation system.
  • said device attaches using a quick connect attachment to said rehabilitation system.
  • said device is counter balanced when attached to said rehabilitation system.
  • said device is attached in a manner which reduces gravitational strain on a patient' s head.
  • a head-worn adjustable electrode device comprising: a body; and a plurality of electrodes attached to said body and selectively positionable relative to a head, when said body is worn on a head, said body being adapted for selective positioning of electrodes.
  • said body comprises a band and comprising a plurality of electrode supports circumferentially arrangable on said band.
  • at least one electrode support is an elongate electrode support defining multiple attachment positions for an electrode thereon.
  • said body is adjustable.
  • said body is plastically deformable.
  • the device comprises at least one brain stimulation device coupled to said body and whose position is adjustable relative to said body.
  • said electrodes and said stimulator are selectively positionable substantially anywhere on at least half the surface of said hemisphere.
  • a method of treating a patient comprising: mounting a plurality of brain activity sensors on the patient using a head-worn device; rehabilitating the patient utilizing signals from said sensors, at least at a clinical setting and at a home setting, using a same device design.
  • a same device is used in multiple settings over a period of time of at least one week.
  • a method of rehabilitation management comprising: providing a plurality of patients; while said patients are in a same care location, setting brain stimulation parameters for said patients by a therapist; rehabilitating said patients at said care location by a person other than said therapist, not under the direct attention of said therapist; and monitoring said rehabilitation and an effect of stimulation by said therapist.
  • said stimulation is externally applied stimulation.
  • an external head-mounted brain stimulator comprising: at least one sensor input; a stimulator adapted to stimulate a brain; and circuitry which prevents stimulation responsive to signals from said sensor input.
  • said sensor input comprises an EEG input and/or Near-infrared spectroscopy (NIRS) input.
  • NIRS Near-infrared spectroscopy
  • said sensor input comprises a positioning indicating input.
  • said sensor input comprises a contact-quality indicating input.
  • a rehabilitation system comprising: at least one articulated arm having a stimulator mounted thereon; a patient support positioned so that a head of a patient can be selectively stimulated at multiple locations using said stimulator; and a helmet adapted for mounting on the patient's head.
  • said helmet includes a plurality of positionable sensing electrodes.
  • said stimulator is selectively attachable to said helmet.
  • said helmet is rigidly attached to said support.
  • a method of enhancing the accuracy of sensing or modifying brain activity comprising: placing in proximity to brain, at a first position, a sensing or stimulating element such that a certain effective brain volume is associated with the element; operating the element; causing measured motion of a body part; analyzing a relationship between said operating and said motion; and selectively moving said element to a new position in proximity to the brain, based on said analyzing.
  • the method comprises causing measured cognitive activity.
  • the analyzing comprises analyzing cognitive activity
  • said element is external to the body. Alternatively or additionally, said element is internal to the body.
  • a method of rehabilitation of a patient using an external sensing array, a rehabilitation system and an internal stimulator comprising: stimulating a brain of the patient using said internal stimulator; locating an external sensing array in a position where it can sense brain activity; causing activity of said patient using said rehabilitation system; sensing brain activity using said array; and modifying at least one of said stimulating, said causing and said parameters of said sensing in response to at least one of a signal generated by said sensing and an effect of said causing other than on the brain.
  • the method comprises applying external stimulation.
  • said external array comprises a controller which controls said internal stimulator.
  • Fig. 1 is a side schematic perspective view of a rehabilitation system including a brain sensing and stimulation system in accordance with an exemplary embodiment of the invention
  • Fig. 2 is a block diagram of a rehabilitation system in accordance with an exemplary embodiment of the invention
  • Fig. 3 is a schematic illustration of a stimulation and sensing helmet and an attachment thereof to a patient and a support, in accordance with an exemplary embodiment of the invention
  • Fig. 4 is a schematic illustration of an adjustable electrode portion of the helmet of Fig. 3, in accordance with an exemplary embodiment of the invention
  • Fig. 5 illustrates an alternative external stimulation element, in accordance with an exemplary embodiment of the invention
  • FIG. 6A and 6B illustrate helmet designs in accordance with alternative embodiments of the invention
  • Fig. 7 illustrates an articulated arm based positionable stimulator for rehabilitation, in accordance with an exemplary embodiment of the invention
  • Fig. 8 is a flowchart of a method of rehabilitation, in accordance with an exemplary embodiment of the invention.
  • Fig. 9 is a flowchart of a process of rehabilitation, in accordance with an exemplary embodiment of the invention.
  • Fig. 10 is a schematic representation of an therapy system according to an exemplary embodiment of the invention.
  • Fig 11 is a simplified flow diagram of a treatment method according to an exemplary embodiment of the invention.
  • Fig. 12 is a simplified flow diagram of a treatment method according to another exemplary embodiment of the invention. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS Overview
  • Fig. 1 is a side schematic perspective view of a rehabilitation system 100 including a brain sensing and stimulation system (helmet) 106 in accordance with an exemplary embodiment of the invention.
  • system 100 is used for rehabilitation of patients that suffer a stroke (e.g., paretic event), which reduces motor, cognitive and/or perceptive abilities.
  • System 100 may also be used for other types of rehabilitation, for example, cognitive rehabilitation, or after body damage, after body disuse and/or for artificial limbs and/or brain/nerve interface prostheses.
  • Non-rehabilitation uses are possible as well, for example, task or athletic training.
  • System 100 is shown in the form of a rehabilitation device, for example, a chair 104 that can be used to support movement of limbs of a patient 102. As will be described below, rehabilitation can be provided in accordance with some embodiments of the invention without a movement support.
  • chair 104 can operate in a "guided mode" and is adapted to actively move hands, legs, head or back of a patient seated therein as part of a therapy program as described below.
  • movement of hands, legs, head or back of a patient seated is in response to a measured brain activity.
  • the patient can adjust chair 194 by moving hands, legs, head or back to reposition corresponding portions of the chair.
  • active patient repositioning of a portion of the cair comprises a therapy task.
  • movement of hands, legs, head or back of a patient seated chair 104 is sensed (e.g. via an sEMG 218; Fig 2) and reported to a helmet controller (e.g. 216 in Fig. 2).
  • one or more of a back of chair 104, an armrest 119 a leg rest 121 and a footrest 123 can be fitted with sensors to measure patient initiated motion and/or robotic components to guide patient motion.
  • system 100 provides the functions of measuring brain activity, stimulating the brain and interacting with body movement and/or sensing body motion and/or other (non-brain) physiological parameters. For example, body parts may be moved, stimulated, measurement measured and/or intent of measurement measured, all in relation to brain measurement and stimulation. The system need not relate to movement, for example, the system may relate to pain or other senses.
  • system 100 includes at least one sensing electrode 108 and/or at least one stimulation element 110 (e.g., electrical or vibration). In the depicted embodiment sensing electrode 108 is depicted on a forearm, although exact placement can vary with the type of rehabilitation of a specific exemplary embodiment.
  • sensing electrode 108 and/or stimulation element 110 can be placed in proximity to the mouth (e.g. on cheek , lips, throat, chest or tongue).
  • Sensing parameters relevant to speech therapy include, but are not limited to, lingual and/or buccal movement, velocity of inhaled or exhaled air, jaw movement and contact between two orofaccial body parts (e.g. tip of tongue to upper incisors).
  • an estimation of orofacial movement is made based upon achieved vocalization (e.g of dipthongs, words or sentences).
  • a parametric model of of the human voice generating system is employed and/or parameters are matched to the patient and treatment goals include patient specific parametric changes.
  • a display 114 is used to show instructions and/or to receive input from a patient, for example in conjunction with a voice input, mouse or a joystick 112.
  • joystick 112 is used to measure patient fine motor control.
  • the joystick includes force and/or vibration feedback.
  • a position sensor/accelerometer 118 is provided to indicate limb position and/or movement.
  • analytic circuitry e.g. helmet controller 216 of Fig 2 which can optionally be provided as a PC with an appropriate software module installed
  • the software module guides the patient regarding tasks appropriate to a specific therapy plan and/or provides stimuli associated with the therapy.
  • the software is responsive to inputs from the patient (e.g. via microphone 117 or controller 203 of Fig. 2).
  • the software is interactive and responds to patient input.
  • interactive software alters a degree of difficulty of presented exercises in response to a degree of patient success.
  • interactive software alters a degree of stimulation and/or specific stimulation parameters provided via helmet 106 in response to a degree or type of patient success.
  • patient success is measured primarily by, optionally exclusively by, sensed brain activity.
  • Sensor 118 is generally indicative of recording sensors located on the body outside helmet 106.
  • sensors 118 are specifically adapted to the application of helmet 106 (e.g. microphone 117 and/or electrodes on or near the mouth for speech rehabilitation and/or muscles tone sensors applied to specific muscles for motor rehabilitation of that muscle).
  • a camera 116 is provided to image limb position.
  • one or more stickers having detectable markings on them are used together with the camera, with the sticker attached to a body portion whose movement is to be detected.
  • Non-optical sensors and indicators may be used as well.
  • a microphone 117 is provided, optionally attached to helmet 106 as depicted.
  • Microphone 117 can be used, for example, to record patient speech performance.
  • stereo microphones are provided.
  • a microphone is positioned near OOB ears of the patient so that the patient and/or therapist can listen to the patients voice as the patient hears it.
  • helmet 106 is adjustable to match patient needs, is optionally wholly or partly disposable, does not weigh to heavily on the patient's head and/or includes safety features.
  • helmet 106 can be used in both stationary and ambulatory applications.
  • helmet 106 is used without additional hardware and/or only with hardware available in a house or worn by a patient.
  • the helmet 106 communicates with an external processor (e.g. PC 114 and other sensors wirelessly.
  • wireless communication can be unidirectional or bidirectional.
  • wireless communication can be across a local network or a remote network.
  • Generalized system description Fig. 2 is a block diagram of a rehabilitation system 200 in accordance with an exemplary embodiment of the invention.
  • a dashed box 202 indicates an exemplary motoric rehabilitation system including a controller 203 and a limb motion support element 204, used to support motion of a limb 206.
  • Controller 203 may also be used for higher level functions, for example, planning and tracking of rehabilitation.
  • a remote system may provide these functions.
  • internet, telephone, cellular or other networks known in the art are used for communicating between a control center and system 200.
  • rehabilitation system sometimes includes the helmet and sometimes does not, depending on the context.
  • a dashed box 213 indicates a plurality of different optional measurements of brain activity, including, for example, MU rhythm (214), MAC recording (212), SCP recording 210 and/or other measurements (211). It should be noted that these measurements may be provided using a same or different set of electrodes and processed to extract the desired data. Optionally, internal (to the body) electrodes are read out. This data extraction is optionally carried out by a helmet controller 216 which is optionally integrated with the helmet or is a separate unit. Optionally, this function is provided by system 202 (e.g., controller 203).
  • a stimulator 230 for example, magnetic, heat, electrical, ultrasonic, implanted and/or other known in the art of brain stimulation is provided for stimulation of a brain 208.
  • Such stimulation is optionally general to a class of rehabilitation exercises, for example, independent of the particular exercise being carried out.
  • the stimulation is specific to a certain brain region, for example, a brain region that is linked to a particular exercise or body part.
  • multiple stimulation sources are used, optionally they are used to stimulate the brain simultaneously.
  • multiple stimulation sources can be used for applying anodal tDCS to the ipsilesional hemisphere and cathodal tDCS on the contralesional hemisphere simultaneously.
  • a plurality of sources are used so that multiple points may be stimulated in sequence without manual readjustment.
  • a motor is used to move a stimulation source between positions a head of a patient.
  • a display 228 (paralleling display 114 of Fig. 1) is optionally used to display information related to the rehabilitation or which serves as part of the rehabilitation, for example, when rehabilitating cognitive functions that are not pure motoric.
  • limb motion is measured or caused by limb motion support element 204, for example a robotic actuator.
  • measurement is provided by the user moving a joystick or a mouse or other input element, and patient input analyzed to determine movement and/or effect.
  • electromyographic measurement is performed, for example using a multi-channel surface electromyography (sEMG) recording device 218, on a healthy and/or paretic limb.
  • a monitor/module 220 is optionally provided for monitoring the recordings.
  • sEMG recordings are correlated with brain measurement signals and/or mechanical output of the patient.
  • a functional stimulator 222 is provided, to provide sub-threshold and/or above threshold stimulation of muscles and/or nerves, in association with sEMG measurement and/or other rehabilitation procedures.
  • the stimulation is provided as a sequence of stimulations of one or more muscle groups, for example in synchronization with a time clock or in response (e.g., and/or delay) to a trigger.
  • the stimulation is electrical or magnetic stimulation.
  • one or more implanted stimulators (wired or wireless) is used.
  • implanted stimulators are used for measuring EMG in addition or instead of being used for stimulation.
  • the stimulators are replaced by reading devices.
  • Wireless implantable electronic stimulators have been described, for example in: U.S. Pat. No. 5,193,539, U.S. Pat. No. 5,193,540, U.S. Pat. No. 5,312,439, U.S. Pat. No. 5,324,316, U.S. Pat. No. 5,405,367, PCT Publication WO 98/37926, PCT WO 98/43700, PCT Publication, WO 98/43701 Oct. 8, 1998, U.S. Pat. No. 6,051,017, US application Ser. No.
  • a mechanical performance monitor module/software 224 is provided, for example, for assessing quality of motion and/or other motion parameters.
  • the actual motion is compared to planned motion.
  • Data may be processed and or stored remotely, for example, at a mechanical activity processing and storage unit 226.
  • a camera 215 (optionally paralleling 116, Fig. 1, but no necessarily head mounted) is provided.
  • a camera may be used, for example, to provide feedback to a patient, to acquire and capture images which can be analyzed to determine quality of motion, for assisting interaction with a remote or a local therapist (e.g., allowing a simultaneous view of more than one portion of the patient and a view of a portion without requiring the therapist move) and/or to generate cuing movies for indicating motions to a patient.
  • a camera and/or a position sensor are used to detect patient motion instead of using a manipulator.
  • images of the camera are automatically analyzed to generate trigger events which control what data is logged. For example, motion of a certain type in a particular field of view of the camera may be considered a suitable trigger.
  • system 100 includes a means, such as circuitry, for timing a provision of the drugs relative to the rehabilitation activity and/or stimulation.
  • a therapist display 217 is provided, for example for showing instruction and/or feedback to a therapist.
  • This display may be remote, for example.
  • a virtual reality (VR) system 219 is provided, for example including one or more of visual goggles, a panoramic display, 3D sound, tactile sensors and/or tactile feedback.
  • the VR system is used to better emulate real-world situations a patient is to be rehabilitated for.
  • the VR system is used to enhance reality, for example by showing a desired motion overlaid on a view of the patient showing his limbs actually moving.
  • a standard display is used, in which a captured video stream is enhanced.
  • feedback to the patient is provided using music.
  • audio feedback and/or voice control are provided in the helmet using a speaker (not shown) and/or microphone 117.
  • the speaker is provided as an earphone, optionally connected to or installed in helmet 106.
  • earphones provide audio feedback and/or task instructions.
  • earphones are useful in cognitive rehabilitation and/or motor rehabilitation with auditory feedback because they contribute to a reduction in auditory distraction.
  • earphones contribute to therapy success in rehabilitation of hearing impaired, visually impaired or ADD subjects and/or when treatment occurs in an environment with significant distraction from non-therapy stimuli (e.g. outdoors or in a "gymnasium" where other patients are treated concurrently) by delivering audio information to the patient at a volume that overcomes audible distractions.
  • rehabilitation therapy is provided to a patient using virtual reality as a tool for interacting with the patient.
  • a test is made to determine which virtual reality setting has a most calming effect on a patient or otherwise interacts favorably with the rehabilitation process.
  • EEG or other brain measurements are used to determine the effect on the patient.
  • EKG or other physiological measurements are carried out, for example, to detect a safety problem associated with rehabilitation and/or stimulation.
  • virtual realty comprises presentation of a video and/or animation sequence.
  • the helmet and/or rehabilitation system include a logging function.
  • the logging includes one or more of: signal application parameters, actual applied signals (e.g., based on measured impedance and/or electrical sensors, not shown), variations in applied signals, measurements, positions of electrodes (e.g., using encoders), motor effects (e.g., limb positions), user input (e.g., voice commentary by user or data entered using an input device such as a keyboard), trigger events (e.g., in daily use) and/or home computer use, when the computer is linked to the helmet (e.g., using a wireless or wired link).
  • signal application parameters e.g., actual applied signals (e.g., based on measured impedance and/or electrical sensors, not shown), variations in applied signals, measurements, positions of electrodes (e.g., using encoders), motor effects (e.g., limb positions), user input (e.g., voice commentary by user or data entered using an input device such as a keyboard), trigger events (e
  • camera recordings are also stored.
  • triggering events and/or measurement values may be set which determine when logging will be carried out and of which variable or variables.
  • a periodic uploading e.g., using a cellular connection or by asking patient to plug into a data transmission device, such as a computer or telephone socket
  • a logging element separate from the helmet is provided, for example, worn by the patient.
  • system 100 includes one or more safety features.
  • helmet controller 216 prevents stimulation if the received EEG signals do not match a desired pattern.
  • stimulation is blocked based on physiological measurements and/or on a lack of correct placement of the stimulator.
  • patient tremor or falling are detected using an accelerometer and used to prevent stimulation, stop rehabilitation exercises and/or initiate a call for help.
  • helmet controller 216 blocks sensing and/or amplification and/or processing of signals by the sensing electrodes when electrical and/or magnetic stimulation are applied.
  • Fig. 3 is a schematic illustration of stimulation and sensing helmet 106 and an attachment thereof to a patient and a support, in accordance with an exemplary embodiment of the invention.
  • the helmet includes, in general, a head band 302 on which are mounted a plurality of electrode elements 301.
  • An optional resilient element 304 is used to ensure contact with the skull and/or provide an elastic coupling between the head band and the skull.
  • a magnetic stimulator 306 (an alternative embodiment is shown in greater detail in Fig. 5), is optionally mounted on a track element 308, and is movable along it.
  • the track element is mounted on a rotary joint 310 (which optionally includes a locking knob), so that the stimulation can be aimed at various locations in the skull.
  • a depth control (not shown) is provided for the stimulation, for example, by providing relative displacement between two coils used in magnetic stimulator 306, for two-coil designs.
  • a, radial motion relative to the skull is provided, for example with a distance adjusting screw (e.g., distance between stimulator and skull or distance between stimulator and the track on which it rides).
  • one or more motors or other actuators are provided for moving the stimulator.
  • one or more position/motion encoders are used to report on the stimulator position.
  • the stimulator is not mounted on the band, so as to not directly pass forces thereto.
  • One or more quick connect couplers 312 are optionally provided for attaching head band 302 to a rehabilitation chair. This attachment may prevent strain caused by the weight of the stimulator.
  • the quick connect coupler allows connection in one step or two or three steps. Alternatively or additionally, the quick connect takes less than 3 minutes, less than 1 minute, less than 30 seconds, less than 10 or less than 5 seconds.
  • a counter- weight 318 is provided to balance the weight of stimulator 306.
  • the attachment between the helmet and the chair is adjustable. This may increase patient comfort.
  • a first coupling joint 314 may provided horizontal motion and/rotation and/or a second coupling joint 316 may provide vertical movement and/or rotation.
  • An articulated arm design or other designs may be used instead.
  • an articulated arm design or other design which supports the helmet while providing low or zero resistance to patient head movement, are provided.
  • Fig. 4 is a schematic illustration of an adjustable electrode portion 320 of the helmet of Fig. 3, in accordance with an exemplary embodiment of the invention.
  • portion 320 is provided with an adjustable sliding buckle 322.
  • band 302 is deformable by hand to match a skull shape.
  • one or more cushions are provided.
  • a plurality of electrode support elements 326 is provided. Each such element optionally has an electrode 328 mounted thereon.
  • a common ground electrode may be provided, or a pair (or more) of stimulation electrodes may be provided.
  • one or more of electrodes 328 is an electrode array.
  • one or more of support elements 326 is elastically biased towards the skull, for example, to assist electrical contact.
  • one or more small electrically conducting plates are glued to the skull (e.g., using conductive glue) for ensuring good contact with the electrodes and maintaining good and/or repeatable conductive contact with the skull.
  • a base section 330 of electrode support 326 rides on band 302 and optionally locks or clicks at set locations, for example, based on notches 324.
  • a motor is used, for example, an electrode motion motor 332 and/or a band position motor 334 for positioning the electrode support.
  • a motor for example, an electrode motion motor 332 and/or a band position motor 334 for positioning the electrode support.
  • position and/or motion encoders are provided.
  • the electrodes are moved under computer control, for example, as part of a process of sensing and/or stimulating at new locations and/or as part of a search for a best sensing/stimulation location.
  • the positioning may be based on the effect of stimulating and/or on the type of signal detected.
  • the type of signal is evaluated in conjunction with limb stimulation and/or motion as caused by and/or measured by system 100.
  • one or more system setup positions for the electrodes are provided.
  • a user e.g., therapist
  • the electrodes and/or stimulator are arranged to cover a significant part of the skull overlying the brain.
  • the part covered is sufficient to selectively stimulate or measure from at least 30%, 40%, 50%, 60%, 70%, 80% or more of the cerebral cortex.
  • the resolution of selective placement (on skull) is better than 3 cm, better than 2 cm, better than 1 cm, or intermediate resolution.
  • the part covered includes the entire brain.
  • the part covered includes a hemisphere of the skull overlying the brain, or at least 30%, 40%, 50%, 60%, 70% or intermediate coverage.
  • the area covered is a portion of the head above a plane defined by the ears and the eyes.
  • the plane is offset by at least 1 cm or at least 2 cm or at least 3 cm from a plane connecting the eyes and ears. Some relative orientations between the measurement start plane and the eye-ear brain may be tolerated, for example, 10 degrees, 20 degrees, 30 degrees or intermediate or greater values.
  • the electrodes are wireless electrodes and include amplifiers.
  • power is provided via the helmet.
  • a common battery is shared by all the electrodes, for example, incorporated in buckle 322 or in a non-disposable part of the helmet, for example associated with helmet controller 216.
  • the helmet when the helmet is attached to a rehabilitation device, it receives power from that device and/or recharges its battery.
  • each electrode reads different lines of this bus and/or is encoded with a different ID code.
  • one or more positioning sensors are provided.
  • sensors 340 are provided to ensure the helmet is correctly placed.
  • one or more markers are attached to the patient and/or marks made on the patient's skin. Positioning sensors generate a "correct positioning" signal if the sensors are aligned with these marks.
  • sensors 340 are movable. In an exemplary embodiment of the invention, the markers generate an electrical signal and the sensors read this signal.
  • the electrodes are of a type that can read through a patient's hair, for example, including conical tips that touch the scalp.
  • the electrodes comprise standard disposable electrodes that attach to elements 326.
  • SQUIDS or other magnetic sensors and/or NIRS or other optical sensors or other brain activity sensors are used instead of electrodes.
  • optical sensing provides an indication of how much work, in general, is being done at a specific brain location.
  • EEG sensors provide a high degree of temporal sensitivity.
  • band 302 and/or elements 326 are provided with markings indicating a standard coordinate system of the skull.
  • the marking is via LEDs or other electronic display.
  • a patient specific map or distortion of a standard map
  • a set of stickers which are applied to the helmet.
  • the helmet is patient specific.
  • band 302 and/or elements 326 can be plastically deformed to conform to a patient's skull.
  • parts of the helmet that contact the patient are disposable.
  • the entire helmet except for the controller and/or stimulator are disposable.
  • disposable means that they can only be used with one patient, for example, by deformation to fitting the skull preventing further deformation or by locking of electrodes in place preventing further motion of electrodes.
  • a single helmet, once adapted for a user may be used multiple times by that user, in multiple situations. Optionally, once adjusted, the helmet need not be adjusted again.
  • helmet portion 320 weighs less than 500 grams, less than 200 grams, less than 100 grams or an intermediate weight.
  • the helmet is made of plastic with some electrical wiring and/or deformable metal wires.
  • the electrodes include local amplifiers.
  • a separate unit with a power source and/or controller 216 is provided, for example, optionally for wear on the neck, shoulder and/or waist.
  • Fig. 5 illustrates an alternative external stimulation element 500, in accordance with an exemplary embodiment of the invention.
  • a stimulator 504 comprising two coil sections 506, 508, is mounted underneath a track element 512 by a riding element 510.
  • a selective locking button 514 is optionally provided.
  • a base 502 of track element 512 optionally includes a hinged mounting (not shown) for rotation of the track and stimulation element.
  • motors, position encoders and/or displays may be provided, for example, to indicate when a correct position is achieved and/or indicate a suggested movement direction.
  • Element 500 can replace elements 306, 308 and 310 in Fig. 3.
  • Alternative helmet designs can replace elements 306, 308 and 310 in Fig. 3.
  • Fig. 6A and 6B illustrate helmet design features in accordance with alternative embodiments of the invention.
  • Fig. 6 A shows a helmet design 600, including an optional ear electrode 610, used as a reference. Electrode 610 is optionally plastically deformable to adjust its position. In the embodiment shown, a band 602 is not adjustable, but rather uses a padding 612 for fitting purposes. This padding may be molded to fit a particular patient. A plurality of electrode supports 604 are optionally plastically deformable. Optionally, the electrodes supports or the electrodes (not shown) are elastic at their tip. Also shown is a stimulator 608, which is optionally mounted on the helmet. Optionally, the helmet is rigidly mounted on a chair.
  • Fig. 6B shows an alternative helmet design 630, in which attachment to a chair is via a support 644 which attaches to a joint 646 at a side of helmet 630.
  • This joint optionally allows motion of the helmet during use, for example, in response to and by patient head motions. Additional motion may be allowed by the connection of support 644 to a rehabilitation system (not shown).
  • a stimulator 642 is mounted on a track 640 which is coupled separately to support 644.
  • an elastic connection is provided between the stimulator and the electrodes, so as to reduce mechanical coupling between them.
  • helmet 630 Also shown in helmet 630 is an alternative adjustable electrode design, in which a cap 638 is provided mounted on a head band 632 and including a plurality of tracks 634 in/on which electrodes 636 can travel.
  • cap 638 is elastic, for example being made of a rubber membrane.
  • the tracks are provided at locations where measurement of electrical signals is typical.
  • the cap is locally conductive, for example, including small sections of conductive material, which are non-contiguous, so that electrical signals can pass through the cap but not along the cap.
  • helmet 630 is preset with a limited number (e.g. 1 or 2 or 5 or 10) tDCS of programs.
  • the programs consider a side of the brain which is damaged. Articulated arm system
  • Fig. 7 illustrates a system 700 including an articulated arm based positionable stimulator for rehabilitation, in accordance with an exemplary embodiment of the invention.
  • system 700 generally comprises a rehabilitation station 702, for example a rehabilitation chair with a joystick/handgrip 706.
  • a display 704 is optionally provided for displaying instructions and/or feedback to a patient.
  • a motion mechanism 708 (shown schematically) is optionally used to move and/or measure movement of joystick 706. It should be noted that other rehabilitation designs are possible as well.
  • a positionable stimulator optionally comprises a stand 710 on which one or more articulated arms 712, 714 are provided. In use, these arms are used to position one or more stimulators 716 and/or electrodes 718 relative to a patient's skull.
  • a helmet is provided with sensing electrodes and only the stimulation is based on articulated arms.
  • the sensing electrodes are not part of the helmet.
  • a helmet-like element for example, a cap or hat, is provided with a grid and/or a plurality of holes or tracks at set locations to ensure correct placement of electrodes and/or stimulators.
  • the helmet is manufactured or modified to match a patient's needs and/or skull shape.
  • additional arms for example, 3, 4, 5 or more articulated arms are provided.
  • the moving elements e.g., electrodes, stimulators
  • the moving elements are adapted to lock or latch onto the helmet to prevent inadvertent motion thereof or allow patient head motion.
  • the articulated arms passively follow such motion, optionally with a small amount of resistance (e.g., enough to reduce the weight felt by a patient when there is no motion).
  • the arms actively move when they sense force applied to them, for example using robotic technology as known in the art.
  • the locking/latching mechanism comprises vacuum and/or a click attachment.
  • Fig. 8 is a flowchart 800 of a method of rehabilitation, in accordance with an exemplary embodiment of the invention.
  • a loop is closed which includes stimulation and body response.
  • the loop also includes measurement of electrical activity in the brain.
  • the loop is closed on a short- term basis, for example, sensing immediately if a stimulation had an effect on electrical and/or motor behavior of a patient and modifying stimulation and/or exercise accordingly.
  • the loop is closed on a longer-term basis, for example, changing stimulation parameters after significant information is collected regarding patient performance and/or after an effect of stimulation is measured or believed to be over.
  • the time scales of closing the loop can be, for example, 1-60 seconds (for example 10), 1-60 minutes (for example 10), 1-10 hours (for example 2) and/or 1-10 days (for example 7 days) or longer or intermediate times.
  • An example of closing the loop on generally longer time scales is detecting that stimulation fails to give an improvement in rehabilitation improvement over a non- stimulation case.
  • every several stimulated exercises one or more non-stimulated exercises are performed to see if patient improvement is indeed enhanced by stimulation. If the answer is negative or if improvement is hampered, stimulation parameters are optionally changed. Optionally, a reduction in amount of improvement is tracked to predict when stimulation parameters will need to be changed (which may require a particular professional).
  • a stimulation is applied. This stimulation is shown being applied before a rehabilitation plan is formulated and/or a patient performs a motion (804), for example, in order to assess negative and/or positive effects of stimulation before proceeding. The order may be changed.
  • various neurological measures are taken, for example, SCP. In some cases, the measures are taken before patient action happens.
  • various physical measures are taken, for example, motion, sEMG and other measures for example as described above.
  • the measures are optionally analyzed to determine rehabilitation improvement.
  • stimulation parameters and/or position may be changed (814).
  • 808 and 806 may be used to indicate side effects, for example, spasm, caused by stimulation.
  • 808 through 810 and 814 may be carried out before and during a single motion by a patient. In particular, they may be carried out during a preparatory stage of the motion.
  • the motion is actually carried out and stimulation parameters may be changed (814) in view of the actual motion.
  • the measures may be changed, for example, responsive to patient improvement, change in exercise and/or lack of usable data.
  • stimulation parameter setting and/or the act of stimulation are carried out by a neurologist.
  • the following are (additional) exemplary scenarios.
  • a. The helmet is made MRI compatible and fMRI imaging is applied in conjunction with electrical measurement and/or stimulation, optionally during the use of a limb robotic manipulator.
  • a head-fMRI device is provided mounted on a separate (e.g., robust) articulated arm.
  • a Neurologist reviews, for example, signals measured from one side of the brain and estimates what signals he would like to see on the other (damaged) side of the brain and sets stimulation and/or rehabilitation parameters accordingly.
  • the analysis can be more detailed.
  • the analysis comprises an evaluation session in which motor abilities and/or cortical impairment are scored.
  • the evaluation session includes collection of data useful in calculating a brain plasticity index (BPI). Exemplary considerations in calculation of a BPI are described hereinbelow beginning in "Exemplary customization of stimulation protocol".
  • BPI contributes to a treatment recommendation by allowing the neurologist to evaluate the specific type of reduction in cortical function in the context of the specific patient.
  • Optimal electrode placement is determined for sensing by moving electrodes in conjunction with stimulation and/or movement or stimulation of limbs by the rehabilitation device until a the measured signal is optimized and/or improved.
  • Controlling implanted electrodes is determined for sensing by moving electrodes in conjunction with stimulation and/or movement or stimulation of limbs by the rehabilitation device until a the measured signal is optimized and/or improved.
  • implanted electrodes, for stimulation and/or sensing are controlled by the helmet, for example, helmet controller 216 sends commands to and/or reads data from the helmet.
  • the commands and/or data readout are via a communication channel provided in an implanted stimulator or in an external stimulator with implanted electrodes.
  • the helmet and/or rehabilitation devices are used to determine which stimulation settings are useful in the implanted device.
  • these settings are programmed in and can be used also without the rehabilitation system and/or at home.
  • one of the settings determined is the timing and/or triggering of stimulation.
  • a setting comprises electrode section.
  • a setting comprises signal amplitude, for example, selecting, using the systems and methods as described herein, what signal amplitude has a useful effect and/or reduced side effects.
  • rehabilitation in conjunction with stimulation combines a rehabilitation device as described herein or in the PCT applications listed below and an implanted stimulator.
  • some stimulation (and/or sensing) is provided using an implanted stimulator and some using a helmet as described herein.
  • sensing of EEG from multiple and/or non-stimulated parts of the brain is easier with a helmet than with an implanted stimulator and is used to help configure implant settings.
  • external stimulation for example DC electrical stimulation may be applied for longer continuous periods of time than internal stimulation, as there is no direct electrical contact between the electrode and the brain. This may reduce polarization, ionization, charge transport problems and/or other problems typically associated with brain electrodes.
  • external stimulation is used together with internal stimulation with the external stimulation generally stimulating a larger brain area a certain amount and the internal electrode enhancing stimulation (with a same or different signal type) in a sub-portion or in a partially overlapping area.
  • accuracy/selectively of external stimulation is enhanced by providing more exact feedback on the beneficial and/or side effects of stimulation parameters and/or location.
  • a stimulator is fixed in place or scans an area and multiple stimulation settings are tried until a desired stimulation effect is achieved. It should be noted that one cause of reduced accuracy of such determination in the prior art is simply relative motion between the simulator and the patient (e.g., when a stimulator is hand-held). This is optionally remedied using a coupling as described herein.
  • the stimulation may be synchronized to brain activity and/or motor activity in various manners, for example, in a positive manner and/or a negative manner, for example, using positive or negative rules.
  • rules may be provided (e.g., by a therapist, based on negative experience with this or other patients) as to when stimulation is not to be applied in addition to providing a general scheme describing when stimulation should be applied (e.g., time based periodic).
  • stimulation may be avoided during a motion planning stage (e.g., based on EEG measurement), while patient body is in motion (e.g., using an accelerometer) and/or when patient is awake (or asleep) (e.g., based on EEG signal).
  • Exemplary positive synchronization rules include stimulating at the times mentioned above and/or at set (or calculated) delays relative to them.
  • stimulation rules may define maximum allowed amplitudes and/or sequence shape and/or length (or other parameter limitations) at certain times and/or what sensed signals to log and at what delay and/or duration relative to the stimulation, hi an exemplary embodiment of the invention, a set of rules is applied and remains in force for a set or calculated time, responsive to a trigger, for example, patient input, a patient activity and/or sensing physiological signals. Cortical "fingerprints" of specific movements / movement's intention
  • a patient is trained to generate selectively EEG patterns associated with imagination of different simple motor actions, such as right or left hand movements.
  • the patient can be presented with one or more biofeedback signals including, but not limited to audio feedback, visual feedback and motor feedback (e.g. a therapy robot manipulates a limb if a correct type of brain activity is produced.
  • a degree of correctness of brain activity is assessed in terms of one or more of magnitude, position and timing.
  • negative feedback is provided to the patient if the correct type of brain activity is not achieved.
  • cortical fingerprints for specific movements are identified, for example a fingerprint for the motion of pushing the hand forwards, in comparison to a fingerprint which is recorded by moving the hand leftwards (or backwards, or upwards etc.).
  • cortical fingerprints for specific movements are identified, for example a fingerprint for the motion of pushing the hand forwards, in comparison to a fingerprint which is recorded by moving the hand leftwards (or backwards, or upwards etc.).
  • the patient will imagine one of several actions (e.g.
  • n-dimensional feature vector is optionally defined. These vectors are optionally used to establish a patient-specific classifier that determines, from the EEG, which action the patient is imagining.
  • a "cortical fingerprints movement related dictionary" that matches a specific cortical activation to a specific movement is generated.
  • the movements are carried out only in the mind.
  • a comparison between imagined and actual motions is stored.
  • a patient stores such patterns before a paretic event, for example, as part of a regular checkup or when danger is identified.
  • the system can use the classifier (i.e. the "dictionary") to translate the patient's motor imagery into a continuous output (e.g. moving the robot arm in the desired direction), and/or into a discrete output (e.g. initiating robot movement).
  • This output can be presented to the patient as, for example, i) a sensory feedback through his hand, and/or ii) through online visual/acoustic feedback on the computer screen. Other feedback means can also be used.
  • the patient will actually move his unaffected hand and/or the affected hand which is connected to system 200, or manipulator 204 will move the patient's hand during the sessions.
  • a set of one or more, optionally dense, electrodes arrays may be used to record brain activity during these movements.
  • This activity will be compared to the activity recorded during the imagined movements in order to find correlations in brain activity during imagined and actual movements. These "cortical fingerprints” of a movement will then be optionally used to "guess" the patient's intention and to carry out the desired movement.
  • FIG. 9 is a flowchart 900 of a process of rehabilitation, in accordance with an exemplary embodiment of the invention.
  • a particular feature of some embodiments of the invention is that a same design or even physically same rehabilitation device can be used in multiple situations and can be associated with a particular patient, optionally due to low cost and/or lightness and/or configurability.
  • the helmet of figs. 3-5 can be used in bed, at home, while walking and at a clinic.
  • the helmet can be used without an associated rehabilitation system and used to track brain activity and/or effect of stimulation on such.
  • the stimulation tracked may be externally applied or internally applied.
  • the stimulator may be mounted on the helmet or electrical stimulation may be provided.
  • a same helmet can attach to multiple rehabilitation systems, including a chair, a whole body system, an arm system and wireless connection with computer based rehabilitation.
  • a patient is diagnosed, for example, by a neurologist in a neurology clinic.
  • rehabilitation is applied.
  • the rehabilitation is applied by a nurse at the clinic with the neurologist applying the stimulation, changing stimulation parameters (906), changing rehabilitation settings and/or monitoring progress and/or side effects.
  • this allows a single neurologist to monitor the rehabilitation of multiple patients which are located at a same rehabilitation clinic/building, for example, within walking distance or in neighboring rooms.
  • some of the monitored patients are monitored by remote, for example, using a network to transit data and/or an image (e.g., video) of the patient response to stimulation.
  • a single stimulation can have an effect that lasts for several (e.g., 5-10) minutes, while side effects may be/ ought to be visible within 1 minute. This provides a window of time for a neurologist to move to another patient and/or activity.
  • rehabilitation is continued elsewhere, for example at a patient's house or at a rehab clinic (e.g., without direct neurological supervision).
  • the same stimulation settings are used and the helmet will fail to stimulate if not positioned properly.
  • the helmet measures impedance of electrode pairs and will not stimulate if impedance is improper, e.g., outside a range for the stimulation electrodes and/or sensing electrodes.
  • the helmet sends data indicative of the neurological state of the patient to a monitoring station, for example, one manned by a neurologist.
  • a single stimulation setting and/or logic of settings may continue to be useful (without modification by a neurologist) for several days or weeks, during which the patient can continue rehabilitation without direct attention of the neurologist.
  • rehabilitation at home uses a personal computer, optionally with no special equipment attached.
  • the helmet communicates with the computer, for example, using an IR link, a Bluetooth link (an example of local wireless) or via a cellular (an example of large area wireless) or other wireless network, or using a wired network, for example, including a cable that plugs into a USB port.
  • software executing on the computer for example, downloaded from a web site or provided by (e.g., stored on and uploaded) or with the helmet, is used to instruct the user to carry out motions (e.g., with a mouse, joystick and/or keyboard) and these instruction are used to assess patient state and/or as a series of rehabilitating exercises. Stimulation and/or EEG measurement may supplement such diagnosis and/or rehabilitation.
  • mouse movements can represent a significant class of activity where rehabilitation may be useful, for general purposes and/or for re- acquisition of ability to carry out daily activities.
  • software provided by the helmet or otherwise loaded on the user computer provides data regarding the activity of the user. This data is sent to the helmet and/or to a monitoring station, where it is correlated with measurements from the helmet and/or effect of stimulation by the helmet.
  • the helmet generates stimulation signals responsive to patient interaction with his computer.
  • the camera is used to capture the actual activity.
  • data describing the activity is sent from the computer to the helmet and/or monitoring station.
  • EEG sensors suitable for use in the context of exemplary embodiments of the invention are available from, for example, Mind Media BV (Roermond-Herten; Netherlands).
  • NIRS Near-infrared spectroscopy
  • NIRS sensors suitable for use in the context of exemplary embodiments of the invention are available from, for example, ISS (Champaign IL, USA;) and/or Hamamatsu Photonics K.K. (Hamamatsu City, Japan).
  • ISS Chromat IL, USA
  • Hamamatsu Photonics K.K. Hamamatsu City, Japan
  • One of ordinary skill in the art will be able to incorporate a commercially available NIRS sensor (e.g. an Optiplex TS from ISS) into one or more exemplary embodiments of the invention.
  • Representative NIRS techniques are described in, for example, Strangman et al. (2003) Neuroimage 18;865-879; MaM et al. (1997) Med. Phys. 22: 1997-2005; Gratton et al. (1995) J. Cognitive Neuroscience 7: 446-456; Obrig, et al.
  • NIRS sensors contributes to patient compliance with a therapy protocol.
  • improved patient compliance results from a reduction in an amount of skin (e.g. scalp) preparation prior to application of the sensors and/or a reduction in invasivity.
  • NIRS sensors are employed in a helmet configured for home use.
  • NIRS sensors are advantageously employed in conjunction with an electrical stimulation program because they are not affected by electromagnetic noise.
  • NIRS sensors are used concurrently with electrical stimulators in a same helmet.
  • the NIRS sensors neither interfere with, nor are subject interference from, stimulation electrodes.
  • NIRS electrodes contributes to an ability to monitor a larger number of points and/or areas in the brain concurrently.
  • monitoring of a plurality of locations contributes to informativity of the monitoring.
  • NIRS sensors contributes to increased accuracy and/or decreased response time in monitoring AP assessment of brain activation achieved while using a robot.
  • motor performance is correlated to displayed brain activation.
  • response time is sufficiently short that users perceive the sensor output as "real time” feedback.
  • NIRS sensors provide 02
  • Non-invasive optical mapping of the piglet brain in real time optical fibers can be arranged in different patterns to map square or rectangular areas.
  • Exemplary EEG sensors of the type described above measure electro-magnetic signals under the electrode and in a circular area of about 2cm diameter.
  • EEG electrodes are deployed in a set to produce maps of electrical activity in larger areas.
  • the set comprises 64, optionally 48, optionally 32, optionally 24, optionally 12, optionally 10, optionally 8 electrodes or lesser or intermediate or greater numbers of electrodes.
  • Exemplary NIRS sensors of the type described above measure hemoglobin oxygen saturation with about the same resolution.
  • NIRS optical sensors are deployed in a set to produce maps of hemoglobin oxygen saturation in larger areas.
  • the set comprises 64, optionally 48, optionally 32, optionally 24, optionally 12, optionally 10, optionally 8 optical sensors or lesser or intermediate or greater numbers of sensors.
  • the sensors are distributed over the entire cranium or are concentrated over a specific area of the brain known to be affected
  • EEG and NIRS sensors are employed together in a single apparatus.
  • the two sensor types map overlapping areas.
  • EEG and NIRS sensors provide complementary information.
  • the complementary information contributes to an increased ability to close a feedback loop.
  • the loop is closed by providing or adjusting stimulation and/or by adjusting therapy tasks in response to sensed brain activity. Exemplary patient acceptance considerations
  • total helmet weight is less than
  • a lower weight and/or a smaller size contribute to increased patient acceptance. Based upon currently available NIRS and
  • a low helmet weight is achieved by using Styrofoam, carbon fiber or other known low density structural components.
  • electric contact with skin contributes to quality of a signal from an
  • skin preparation contributes to an increase in electric contact quality.
  • Skin preparation can include, for example, shaving and/or application of a conductant (e.g. gel or cream) and/or glue.
  • a conductant e.g. gel or cream
  • dry electrodes contribute to an increase in patient acceptance.
  • optical connection via a direct light link with the scalp with skin contributes to quality of a signal from an NIRS sensor.
  • shaving or cutting of hair contributes to provision of a direct light link with the scalp.
  • sensor type is selected in consideration of patient willingness to accept skin preparation and/or hair cutting/shaving and/or in consideration of an anticipated amount of interference (e.g. from sweating and/or motion).
  • exemplary sensor positioning considerations areas in the brain responsible for different activities (motor execution, motor planning, memory, etc.) are known.
  • motor activity is believed to be controlled through a motor cortex.
  • a map of where each body part is controlled is available.
  • an available motor cortex map is employed to position sensors to monitor activity of a relevant body part.
  • stimulation can be implemented by electrical transcranial currents and/or magnetic fields.
  • Electrical stimulation can be, for example, DC, AC, and/or pulsatile and/or oscillative.
  • DC stimulation is applied via external electrodes located in the helmet (e.g. transcranial direct current stimulation; tDCS).
  • tDCS transcranial direct current stimulation
  • anodal tDCS is applied to the ipsilesional hemisphere and cathodal tDCS is applied to the contralesional hemisphere concurrently, optionally simultaneously.
  • the Eldith programmable DC-stimulator (neuroConn GmbH, Ilmenauu, Germany) is suitable for use in some exemplary embodiments of the invention.
  • Interferential Current (IFC) stimulation is applied via external electrodes located in the helmet.
  • IFC is based on the summation of two alternating current signals of slightly different frequency that are delivered using two pairs of electrodes.
  • IFC produces a low-frequency current.
  • the low-frequency component sums to an amplitude that is sufficient to stimulate while no stimulation occurs when the two AC signals are out of phase.
  • the two AC signals that have slightly different frequencies and stimulate is produced by the beat.
  • Oscillating current stimulation is applied via external electrodes located in the helmet.
  • transcranial application of oscillating current stimulation e.g. 0.75 Hz
  • oscillating current stimulation induces slowly oscillating potential fields in underlying neocortical tissue.
  • oscillating current stimulation is applied selectively during defined states of sleep and wakefulness (e.g. during REM).
  • oscillating current stimulation exploits resonance effects occurring in neuronal networks for defined oscillatory rhythms.
  • Magnetic stimulation is applied via external electrodes located in the helmet.
  • rTMS Magnetic stimulation
  • Exemplary rTMS protocols are described by George et al (Neuroreport (1995) 6(14): 1853-6) and by Pomeroy et al. (Neurorehabil Neural Repair. 2007 Apr 4; e-publication preceding print publication). The contents of these articles are each fully incorporated herein by reference.
  • a closed loop between measured brain activity and stimulation contributes to an ability to correctly adjust stimulation parameters independent of stimulation mode.
  • sensors provide feedback on patient response to stimulation delivery and/or task performance.
  • the feedback can provide data pertaining to a patient response to the delivered signal and/or the effect of an incremental change in delivered signal.
  • the sensors are installed in the helmet.
  • data pertaining to patient response to the delivered signal is provided by sensors installed in the helmet (e.g. EEG and/or NIRS) and/or by external sensors (e.g. fMRI) in communication with helmet controller 216 (Fig. 2) as illustrated in exemplary method 1600 (Fig. 11).
  • sensors installed in the helmet e.g. EEG and/or NIRS
  • external sensors e.g. fMRI
  • EEG and/or NIRS sensors are placed in proximity to and/or at a distance from stimulation sources
  • stimulating electrodes are wired to function as sensors.
  • a large number of sensors is employed, each sensor with a known location relative to a subject's cranium and/or brain.
  • sensors are located in the helmet and/or deployed on the scalp. As the number of sensors increases, and/or distance between sensors decreases, spatial resolution improves.
  • 16, 24, 32, 40, 48, 56 or 64 or intermediate or greater numbers of sensors are employed.
  • Fig. 11 depicts an exemplary embodiment of the invention in which a large number (e.g. 32 or more) of electrodes are employed 1610 to determine or map a relevant brain area for subsequent stimulation.]
  • a method of the general type depicted in Fig. 11 serves as a mapping or evaluation stage in a two tiered therapy plan which also comprises a therapy stage.
  • the mapping or evaluation stage employs a greater number of sensors and/or stimulation electrodes than the therapy stage.
  • the exemplary method of Figure 11 relies upon comparison between brain activity during task performance and not during task performance at each location represented by a sensor.
  • the exemplary method of Figure 11 relies upon comparison between brain activity during task performance and not during task performance at each location represented by a sensor.
  • four phases of evaluation with specific related tasks are presented.
  • first phase 1620 screening process designed for evaluation of therapy of a paralyzed hand after a stroke
  • the subject is asked to imagine 1640 a movement of the paretic hand (e.g. in response to a first stimulus) and not to imagine anything 1630 when in response to a second stimulus.
  • the first and second stimuli are visual stimuli (e.g. symbols on a computer screen) or audio stimuli (e.g. passages of music or spoken instructions).
  • symbols comprising visual stimuli are defined in terms of one or more of color, shape, size and position.
  • the second stimulus comprises an absence of the first stimulus (e.g. when the green light is on do "X" and when it goes off, do "Y").
  • Repetition of this first phase continues until a sufficient amount of data is collected.
  • a number of repetitions varies with a degree of variability of the collected data.
  • 30, 40, 50, 60, 70, 80, 90 or 100 or lesser or intermediate or greater numbers of repetitions are sufficient to provide a clinically useful and/or statistically significant data set.
  • an exemplary second phase beginning again from 1620 of the exemplary screening, the subject is asked to imagine 1640 a movement of the non paretic hand (e.g. in response to the first stimulus) and then not to imagine anything 1630 (e.g. in response to the second stimulus). Stimuli and repetition are as in the first phase.
  • an exemplary third phase (returning again to 1620) of the exemplary screening the subject is asked to actually move 1640 the paretic hand (e.g. in response to the first stimulus) and then not to do anything 1630 (e.g. in response to the second stimulus). Stimuli and repetition are as in the first and second phases.
  • an exemplary fourth phase (returning again to 1620) of the exemplary screening the subject is asked to actually move 1640 the non paretic hand (e.g. in response to the first stimulus), and then not to do anything 1630 (e.g. in response to the second stimulus). Stimuli and repetition are as above.
  • data from all 32 electrodes is analyzed and/or processed 1650 by analytic circuitry (e.g. helmet controller 216, optionally using matlab software package; The Math Works Inc.; Natick, MA, USA) to identify or find 1660 a brain area corresponding to an electrode in which the best response is received,
  • analytic circuitry e.g. helmet controller 216, optionally using matlab software package; The Math Works Inc.; Natick, MA, USA
  • mu-rhythm strength is employed as an indicator.
  • mu- rhythm is strongest over the motor cortex, either the damaged or the intact, depending on the cortex lesion. Once the brain area is identified, stimulation is applied through that area.
  • application of stimulation to and/or monitoring of activity in the identified brain area is performed using a device with a relatively small number of electrodes (e.g. 1 or 2 or 4 stimulation electrodes and/or 4 or 8 or 12 sensors).
  • a relatively small number of electrodes e.g. 1 or 2 or 4 stimulation electrodes and/or 4 or 8 or 12 sensors.
  • reducing the number of sensors and/or stimulation electrodes in the "second tier" therapy phse does not significantly reduce sensing resolution and/or accuracy of stimulation delivery.
  • a BCI interface is used for training 1670.
  • Fig. 12 depicts an additional exemplary method of treatment 1700 which implements a closed feedback loop based on measured brain activity.
  • method 1700 can employ any of the different helmet designs and/or sensor types described hereinabove or can rely on other sensor configurations (e.g. implanted sensors).
  • the sensors sense brain activity.
  • sensing begins during a time when the patient has been instructed not to attempt to perform a task.
  • the sensed brain activity is provided 1720 as an output signal.
  • the output signal can be routed to a controller (e.g. controller 1100 of Fig. 10) and/or a computer (e.g. 1040 of Fig. 10).
  • one or more tasks are presented 1730 to the patient.
  • sensing 1710 and providing 1720 of output signal continue as the patient performs the presented task(s).
  • the output signal is analyzed 1740 and/or logged 1760 during performance of presented tasks 1730.
  • performance of presented tasks can be analyzed 1742 and/or logged 1760.
  • tasks are adjusted 1750 responsive to the analyses 1740 and/or 1742.
  • adjusting 1750 occurs during a therapy session in which tasks are performed. For example, a patient that succeeds modifying brain activity to a desired degree after four repetitions of an "imagination based" task, may be presented with a new task without completing a nominal ten repetition cycle.
  • stimulation parameters and/or tasks are changed in the middle of a task.
  • stimulation parameters and/or tasks are evaluated and/or update every 60, 30, 20, 10, 5 or 1 seconds or intermediate or greater or lesser numbers of seconds.
  • adjusting 1750 occurs after a therapy session in which tasks are performed.
  • logging 1760 may involve storage of data in a memory device (e.g. flash memory) and/or transmission to a remote site (e.g. via a network connection available to work station 104).
  • data stored in a log file can be analyzed 1740 periodically (e.g. after every therapy session or every "n" therapy sessions.
  • an increase in n contributes to a decrease in responsiveness of the feedback loop.
  • a decrease in responsiveness of a feedback loop contributes to a reduction in influence of measured noise.
  • brain stimulation 1770 is applied based upon analyses 1740 and/or 1742 using one or more exemplary parameters as described above.
  • applied brain stimulation influences brain activity sensed at 1710.
  • the applied stimulation is evaluated and/or adjusted based upon the activity sensed at 1710. Additional exemplary considerations in motor rehabilitation
  • stimulation of an identified motor area of the brain is adapted to increase excitability of the identified motor area.
  • an intact hemisphere of the brain can be stimulated to inhibit its activation and/or to record normal brain activity for comparison to the impaired activity of the injured hemisphere.
  • brain activity in a healthy brain portion is dampened and/or brain activity in a damaged brain portion is amplified by one or more applied stimulation signals. Additional rehabilitation
  • a helmet and/or methods and apparatus as described herein may also be used for non-motor rehabilitation, for example for speech rehabilitation or (motor) planning rehabilitation.
  • closing the loop, as in registering the effect of stimulation is manual, for example, by a neurologist.
  • the closing is automatic.
  • rehabilitation directed to train a patient in generating a rhythm may be monitored by using an audio input that detects whistles generated by a patient on a whistle and/or generated at a user input using a healthy part of the body.
  • a speech rehabilitation therapy program includes stimulation of the relevant brain area.
  • the relevant area of the brain comprises Broca's area which is known to be is involved in language processing, speech production and comprehension.
  • Broca's are is located in the opercular and triangular sections of the inferior frontal gyrus of the frontal lobe of the cortex. Broca's and Wernicke's areas are found unilaterally in the brain.
  • Broca's area comprises Brodmann area 44, (Mohr (1976 in Studies in
  • Brodmann area 45 (Penfield and Roberts; Speech and Brain Mechanisms (Princeton Univ Press, Princeton, 1959; Ojemann et al.(1989). J Neurosurg 71: 316-26 and Duffau et al. (2003). Neuroimage 20: 1903-14).
  • Broca's Area is connected to Wernicke's area by a neural pathway called the arcuate fasciculus. The corresponding area in macaque monkeys is responsible for high-level control over orofacial actions (Petrides et al. (2005). Nature 435: 1235-38).
  • feedback is received from the patient during therapy.
  • vocal feedback is via microphone 117 connected to helmet 106 (Fig. 1).
  • feedback can comprise measurements of movement and/or tone of relevant facial and/or lingual and/or labial muscles.
  • vocal feedback is analyzed with respect to one or more of amplitude, smoothness, pronunciation correctness and frequencies.
  • analysis is conducted by helmet controller 218 (Fig. 2). Relevant physical response parameters for speech therapy are described above.
  • therapy parameters are adjusted in response to patient feedback immediately and/or based on analysis of progress over time.
  • adjustment includes tuning of one or more stimulation parameters including, but not limited to, stimulation delivery site, electric parameters of stimulation, magnetic parameters of stimulation and temporal parameters of stimulation.
  • adjustable stimulation parameters include, but are not limited to, current, duration, pulsatility and frequency.
  • currents for example 0.5, 1 or 2 mA (or intermediate or greater or lesser values) are initially applied and adjusted as needed.
  • a continuous current is applied for 5, 10, 20 or 40 minutes (or intermediate or greater or lesser times).
  • pulsatility of the current can be in seconds, tenths of seconds, hundredths of seconds or milliseconds.
  • low frequency e.g. 2, 4, 8, 10, 20, 30 or 50 HZ or intermediate or greater or lesser values
  • AC currents are employed for stimulation.
  • the patient may receive speech tasks concurrent with stimulation.
  • Exemplary tasks include word repetition, phrase repletion, reading a passage of text and singing at least a portion of a song.
  • tasks are presented on display screen 114 (Fig. 1) and/or via speakers (optionally earphones; e.g. installed on ear electrode 610; Fig. 6B).
  • a human therapist administers the tasks.
  • tasks are administered via a module adapted for speech therapy.
  • Exemplary adaptations for speech therapy include interfaces to a microphone and/or craniofacial sensors as described above.
  • sensing and/or stimulating electrodes are attached at relevant craniofacial locations.
  • stimulation is provided before and/or during attempts to speak.
  • the patient is shown images of their mouth and/or hears recordings of their voice during task performance with and without stimulation.
  • Exemplary Neurofeedback training is provided before and/or during attempts to speak.
  • helmet 106 is configured as a brain computer interface (BCI).
  • BCI brain computer interface
  • the BCI employs brain signals to issue commands to a computer program.
  • sensors e.g. EEG or NIRs electrodes
  • a BCI controller e.g. computer running BCI software
  • the software analyzes the signals and checks a degree of conformity to a specific goal (e.g. intensity and/or pattern).
  • different responses to a high degree of conformity can occur.
  • the BCI activates a program and/or a rehabilitation system.
  • stimulation supplied through the helmet complements endogenous brain signals of the patient.
  • helmet 106 comprises brain activity sensors (e.g. EEG and/or NIRS).
  • sensor position is verified, for example using positioning sensors 340 as described hereinabove, to assure that brain activity of a correct area is sensed.
  • An exemplary method for selection of a correct brain area is described in detail hereinabove.
  • Output from sensors in the helmet is optionally analyzed by analytic circuitry (optionally a software module). Based upon results of the analysis, the circuitry provides a feedback signal to the patient (e.g. using an installed software module and/or a display).
  • the feedback signal comprises an indication of a degree of patient success in controlling a specific brain activity.
  • the feedback signal comprises one or more of a visual signal, an auditory signal, and a motor signal (e.g. manipulation of a body part by a robotic device or contraction of a muscle by application of a controlled electric current or motion of a pinch and grip device) and an olfactory signal.
  • the feedback comprises at least a portion of a therapy task.
  • the feedback signal contributes to development of conscious control over one or more specific components of neural brain activity which are not typically subject to conscious control.
  • conscious control over one or more specific components of neural brain activity which are not typically subject to conscious control is useful in physical rehabilitation (e.g. stroke patients, TBI patients) or non-physical rehabilitation purposes (e.g. anxiety control or substance abuse).
  • applied stimulation modifies neural activity in the damaged area of the brain (e,g. by rerouting or recruiting).
  • positive feedback to conscious attempts to activate specific brain areas reinforces a connection between the attempted neural activity and the motor function for the patient.
  • a BCI helmet and circuitry to analyze data from sensors and provide a feedback signal to the patient as described above additionally comprises a stimulator (e.g. tDCS).
  • a stimulator e.g. tDCS
  • the circuitry signals the helmet controller which operates the stimulator.
  • the stimulator provides a direct stimulation of the relevant brain areas to produce, or augment during a patient initiated attempt, the desired modulation of brain activity.
  • a designated amount of time is permitted to elapse before the patient is deemed not to have succeeded.
  • the designated amount of time is a few seconds to a few minutes.
  • a feedback signal as described above is optionally provided as soon as modulation of the appropriate brain activity to the desired degree is achieved whether "help" from the stimulator is needed or not.
  • monitoring of patient success in modulation of the appropriate brain activity to the desired degree coupled with stimulation of the brain when needed contributes to increases an overall success rate.
  • patterned activation and deactivation of selected brain areas contributes to cortical reorganization.
  • manipulation of a limb by a robotic device as a feedback for altered brain activity in a relevant brain area can contribute to a patients ability to move the limb without aid of the robotic device.
  • one or more stimulators are operated in conjunction with a specific therapy exercise performed with a robotic therapy device.
  • electrodes which sense an intention to execute a specific motion are then operated as stimulation electrodes to initiate the action.
  • a subset of available stimulation electrodes is activated based upon one or more of a lookup table, a previous calibration session and a medical diagnosis.
  • a subset of stimulators and/or sensors located in or adjacent to a specific brain area are employed when that motion is performed by the robot.
  • timing of stimulation is synchronized with the motion performed by the robot.
  • stimulation provided by the stimulators is adjusted in response to a degree of active participation of the patient in the exercise.
  • adjustment of stimulation comprises adjusting one or more of an amount of stimulation and/or a stimulation parameter (e.g. voltage, current, duty cycle, temporal envelope and total duration.)
  • intensity of current can be increased or reduced as described above and/or stimulation duration can be changed and/or a protocol of the stimulation can be changed (e.g. example, a therapist can try DC and pulsatile protocols and choose the one that has better affect on the motor performances) and/or a subset of stimulation electrodes employed and/or a number of regions to be stimulated (concurrently and/or sequentially).
  • a protocol of the stimulation e.g. example, a therapist can try DC and pulsatile protocols and choose the one that has better affect on the motor performances
  • a subset of stimulation electrodes employed and/or a number of regions to be stimulated e.g. example, a therapist can try DC and pulsatile protocols and choose the one that has better affect on the motor performances
  • a subset of stimulation electrodes employed and/or a number of regions to be stimulated e.g. example, a therapist can try DC and pulsatile protocols and choose the one that has better affect on the motor performances
  • pauses between stimulation sessions during a single session and/or a period between sessions can be varied (e.g. daily, weekly, monthly)
  • Active participation of the patient in the exercise can be evaluated via brain activity (e.g. using EEG or NIRS) or physical measures of exerted force (e.g. accelerometer or resistometer).
  • X repetitions are performed with no stimulation applied.
  • measurements of active participation are conducted during these X repetitions.
  • This methodology may be applied in a manner similar to computer "neural network" training.
  • stimulation electrodes placement is adjusted as a result of measured brain activity based on motor practice (e.g. with the robotic exercise device) ⁇
  • stimulation of the brain during a specific robotic exercise is coupled with deactivation of neural signals to a healthy counterpart organ (e.g.
  • deactivation comprises applying a signal to a relevant brain location and/or one or more relevant muscles.
  • brain stimulation is applied to two or more areas related to a same task.
  • application of the signal to the areas alternates in a rhythm synchronized to the rhythm of the robotic exercise. For example, stimulation at cognitive area during display of a visual stimulus followed (e.g with an expected and/or desired delay for a response from a BCI ) by stimulation of a motor area during manipulation of a body part by the robot.
  • a BCI as described hereinabove is employed in conjunction with a robotic therapy device.
  • a feedback signal comprising robotic motion is delivered to the patient.
  • the feedback signal comprising robotic motion provides important reinforcement when the level of neuronal activity achieved is insufficient to produce motion and/or produce correct motion and/or correct timing of motion of the relevant body part.
  • the robotic motion contributes to motor skills and/or range of motion and/or muscle strength.
  • cortical fingerprint dictionary In an exemplary embodiment of the invention, sensors located in the helmet are used to identify specific cortical activity patterns ("cortical fingerprints") for specific movements.
  • data from sensors e.g. EEG
  • sensorimotor cortex or other relevant brain locations
  • a software module to derive its features.
  • an n-dimensional feature vector will be defined. These vectors can serve as a patient-specific classifier that determines from sensor data (e.g. EEG) what neuronal activity correlates to a specific task.
  • a large number of classifiers serves as a "cortical fingerprints movement related dictionary" that matches a specific cortical activation to a specific movement for a specific individual.
  • any matching method known in the art for example, RMS-closest match can be employed.
  • controller 216 of system 200 Fig.
  • the personalized dictionary of cortical fingerprints for specific movements can be useful for conscious control of a prosthetic limb.
  • the dictionary is built according to healthy limb movements, optionally mirroed to a contralateral limb. Once the dictionary is available, the patients' thoughts and intents of specific movement will be recorded by helmet electrodes, analyzed, and translated into real movements of the artificial arm.
  • cortical fingerprints are used together with stimulating muscles directly, based on emg measured contralaterally.
  • the personalized dictionary of cortical fingerprints for specific movements can be useful for transfer from one side of the body to the other.
  • a dictionary of right hand cortical fingerprints can be used as a template for stimulation to achieve similar movements in a paralyzed left hand.
  • the cortical effects are used to define a required dosage of rehabilitation and/or stimulation and/or to control billing.
  • a match is made between an amount of activity by a user (for example, as measured by actual exercise time or cortical activity) and a therapeutic effect and/or a rehabilitation condition.
  • 20 "active minutes" per day may be the dosage for medium severity pre-motor one damage.
  • a range of possible doses may be defined, for example between a low dosage (not having sufficient effect) and a high dosage (possibly causing over compensation or undue tiredness).
  • the dosage prescribed for a patient is a relative dosage dependent on the patient's total ability and/or total number of rehabilitation issues.
  • system 100 is used to track the actual applied dosage and/or its effect.
  • system 100 can distinguish the actual dosage applied to each area (or issue) in need of treatment. In particular, system 100 may carry out these functions in an ambulatory mode.
  • the dosage is defined as a function of one or more of physical exertion mental exertion and/or attention/engagement.
  • dosage is measured in units of one or more of power, force or energy.
  • system 100 is designed to apply a known amount of dosage and/or decide on changing an exercise schedule, once a certain dosage is reached and/or to prevent over-dosing.
  • dosage is used to define a minimal level required to achieve benefit from rehabilitation, for example, a minimum exertion level or a minimal engagement level may be required.
  • system 100 is used to ensure such minimal attention/exertion levels.
  • attention is measured by measuring compliance and/or variation in response time to instruction.
  • Absolute response time may be of interest, for example, if there is an expected response time based on previous activities. While the present application focuses on physical activities, it should be noted that the methods described herein can also be used for cognitive and perceptive rehabilitation, including the usage of dosage.
  • cognitive and/or perceptive activity is detected directly.
  • a patient is requested to do a physical activity to indicate the cognitive or perceptive activity.
  • the effect of motor signals in the brain is ignored and/or used as a trigger to search for brain activity related to a decision to provide a response.
  • Mental state In an exemplary embodiment of the invention, daily assessment of mental state is carried out as part of rehabilitation.
  • brain image, blood tests and/or EEG measurements are used to assess an instant mental state of a patient, for example, depression or anxiety.
  • additional motivation may be provided and/or lesser achievements may be expected. It should be noted that this type of depression relates to a mood, which can change hourly or daily and not to clinical depression which is a long term illness.
  • cognitive rehabilitation progress is assessed using other means, such as problem solving or other cognitive tests.
  • cognitive progress is used to calibrate expected physical rehabilitation progression, for example, assuming that a same improvement rate is expected for areas with similar damage under similar exercise protocols.
  • an improvement template is adjusted to match a patient based on improvement in one or more functions and used to estimate expected improvements in other functions.
  • a template includes a correspondence between expected improvement rates for areas of different degrees of damage and/or degrees of accessibility to rehabilitation.
  • the template is adjusted according to actual rehabilitation effort.
  • EEG measurements are used to determine settings, environmental cues and/or exercises that promote desired cortical brain activity and/or reduce noise that interferes with detection thereof.
  • the environmental cues are selected from one or more of colors, images, language, or other means that have been documented to cause certain types of emotional reactions in people.
  • a therapist and/or system 100 provide other motivational means, such as motivational talks, movies and positive feedback optionally timed to have a desired effect.
  • system 100 controls simultaneously two or more of physical rehabilitation, brain stimulation, emotional control and instructions.
  • a rehabilitation plan is optimized to take into account the parameters being controlled.
  • brain stimulation and/or an implantable stimulator are used for mood altering. Motion types
  • the motion which is controlled is generally that of a single point, e.g., a tip of the manipulator.
  • the tip may be connected, for example to a bone, to a joint or to a different part of the body.
  • the attachment may be rigid, for example using a strap or it may depend on cooperation of or action by the patient, for example, as a handle or a rest.
  • Specific attachment devices for example for a hand, arm, elbow, knee, ankle and/or shoulder may be provided.
  • Multiple tips (optionally with individual manipulators) may be provided for attachment at different points of the body, on a same or different body part.
  • a) Passive Motion The tip is moved (by system 100) and the patient moves with it.
  • Resisted Motion The patient moves the tip and encounters resistance.
  • the resistance may be of various magnitudes and may be uniform in all direction or be directional.
  • a positive feedback on the manipulator increases the force of motion in the direction moved by the patient.
  • Force Field Motion The patient moves the tip. Along a certain trajectory one level of resistance (or none) is encountered. Deviation from the trajectory is not allowed or meets with resistance. Motion along a "correct" trajectory can be without resistance, or possibly assisted. An increased resistance is optionally exhibited in a volume surrounding the trajectory.
  • a prevention of motion may be provided in an outside volume, hi an exemplary embodiment of the invention, a corrective force vector is applied when not on the trajectory, pointing towards the trajectory.
  • a corrective force instead of a corrective force, resistance varies as a function of distance from the trajectory, thus, motion of the tip is naturally urged back to the trajectory.
  • the force is applied in the direction of the path.
  • the force maybe a unidirectional force of resistance. This type of motion may be used to help train the patient in a desired motion.
  • e) Mirrored Motion Motion of the tip is required to mirror the trajectory of motion of a different element, for example for dual limb rehabilitation as described below.
  • Free Motion Free Motion.
  • Patient moves the tip in any way he desires, possibly receiving feedback.
  • system 100 may record it for future playback.
  • the prerecorded motion (or path) is optionally reconstructed using other modes.
  • the recorded path is modified (e.g., smoothed or otherwise edited), for example automatically or manually.
  • General Force Field A force field and/or an assistance field is defined which is not related to any particular trajectory. For example, a range of trajectories may be allowed to be practiced by a user, or a real or virtual situation simulated (e.g., water, areas with obstacles).
  • h Local Force Field.
  • Restricted Motion One or more points of the body of a subject are supported or prevented from moving. Optionally, the angles between such points and the moving points on the patient are measured. In one example the elbow is locked with a dedicated harness allowing only a shoulder motion. In some embodiments, the restriction is partial and/or is provided by a movable element (e.g., the manipulator).
  • Initiated Motion The patient initiates the motion (e.g., a 1 cm motion or 100 gram force) and system 100 completes or helps the patient complete the motion in space. The completion may be of a whole trajectory or of part of a trajectory.
  • Implied Motion e.g., a 1 cm motion or 100 gram force
  • System 100 begins the motion and the patient completes it.
  • System 100 may assist the rest of the motion in various manners (e.g., by changing to one of the modes described herein after the motion starts). If the patient fails to pick up the motion, system 100 may generate a cue, for example an audio reminder.
  • Different parts of a single motion trajectory may each have a machine initiation definition.
  • system 100 begins the motion.
  • Cued Motion The patient receives a cue from the system before motion according to a different mode starts.
  • the cue can be, for example, vibration of the tip, stimulation pads on the skin, audio or visual cue.
  • the strength of the cue and/or its timing and/or other ongoing activities are used to help train the coordination between different modalities, for example, hand-eye coordination.
  • a motion cue can be used to train a kinesthetic sense.
  • Teach Mode System 100 is taught a motion. In one example, a therapist performs a motion and motion parameters at each point are recorded and can then be used for an exercise. Another way of teaching the system is to use a path that the therapist uses.
  • the therapist may use a control to indicate a point to be taught or a continuous mode may be defined by which an entire trajectory is learned.
  • the path and points are edited before replay.
  • the paths are abstracted, for example, by smoothing or identifying motion points, before playback.
  • Step Initiated The patient initiates the motion (e.g., a 1 cm motion or 100 gram force) and system 100 completes or helps the patient complete the motion in space, however, patient initiated motion occurs in steps and/or increments.
  • a patient generated force in a predetermined "right" direction and/or range of directions must be applied at each step in order for system 100 to complete and/or help the patient complete the motion.
  • a "right” direction is optionally defined as one in which the patient will receive a desired therapeutic benefit for moving in that direction.
  • the steps and/or increments are variable.
  • the steps and/or increments are pre-settable.
  • the completion may be of a whole trajectory or of part of a trajectory. o)
  • System 100 is pre-programmed with at least one point in a path of motion to be followed by the patient.
  • patient initiates motion along the path of motion, optionally assisted by system 100.
  • Motion along the path is optionally conducted at a pre-set speed in some exemplary embodiments of the invention.
  • the speed is not pre-set.
  • motion by the patient in a "right” direction causes at least a brief acceleration in speed instigated by system 100.
  • a plurality of points are used to allow the patient to "connect the dots" in the motion path.
  • "arrival at a point” is determined considering vector of approach, speed of approach, elapsed time prior to arrival, and/or accuracy of arrival to the point.
  • the patient must hold at the point steadily (i.e. no wobble) before being considered to have arrived at the point.
  • the patient is assisted with movement along a predetermined proper path for therapy.
  • system 100 moves continuously at a predetermined speed and whenever the patient exerts a force above a certain level and/or in the right direction), the speed of the exercise is increased.
  • stimulation may be applied at various times, for example, at one or more of before motion of a healthy limb, after healthy motion and before paretic motion, after both motions are completed, after motion starts, at preset times in a motion if/when motion falters and/or for only some motion events.
  • stimulation protocol may be applied at various times, for example, at one or more of before motion of a healthy limb, after healthy motion and before paretic motion, after both motions are completed, after motion starts, at preset times in a motion if/when motion falters and/or for only some motion events.
  • training or therapy sequences are adjusted and/or updated based upon current patient condition.
  • adjustment/update comprises one or more of the following processes.
  • a neurologist determines an initial brain plasticity index (BPI).
  • BPI represents quantitatively a change in neural activity in a relevant brain area.
  • initial BPI is determined based upon data received from the helmet and/or data acquired independently of the helmet.
  • Data acquired independently of the helmet includes, but is not limited to, data from an independent Brain Imaging device (e.g. optical imaging, PET, fMRI).
  • the independent Brain Imaging device is adapted to communicate with the helmet, for example to provide data supplementary to that provided by sensors in the helmet.
  • the neurologist can use a robotic assessment to determine appropriateness of patient as a candidate for internal brain stimulation and/or appropriate stimulation type.
  • a patient response to intense or other robot therapy is measured before the brain stimulation intervention and/or after the stimulation intervention to produce a BPI.
  • stimulation parameters are customized to an individual subject prior to initiation of therapy and/or during therapy based on BPI.
  • Customization during therapy optionally includes one or both of immediate adjustment of stimulation parameters based upon patient response during a single session and delayed adjustment of stimulation parameters based upon patient response during a plurality of sessions.
  • Exemplary evaluation of brain function by BPI In exemplary embodiments of the invention, BPI considers different facets of brain activity. Facets of brain activity include, but are not limited to, strength, duration, typical frequencies, phase, latency of response of the measured activity, and patterns of activation of areas and groups of areas. In an exemplary embodiment of the invention, two or three or more of the facets are measured and compared to normative values to calculate BPI.
  • a contralateral uninjured side of a brain in a same subject is used to provide a normative BPI for a specific task type.
  • use of the uninjured side of the brain in an individual reduces an effect of population variation on normative BPI values for any specific facet of brain activity and/or any specific task.
  • comparison between BPI in the two sides of the brain (injured and uninjured) is repeated during rehabilitation to evaluate progress.
  • adjustment of BPI in the injured brain portion to match BPI in the uninjured side is evaluated as complete success.
  • complete success is judged in consideration of normal differences between sides in an individual (e.g. less dexterity in fingers of the left hand in a "right handed" individual with no brain injury).
  • one goal can to dampen neural activity on the uninjured side, as often after injury it gets too strong and overpowers the injured side.
  • the BPI includes a laterality index which indicates a relative difference between the two sides of the brain.
  • the laterality index indicates an extent of over activation of an intact hemisphere and/or an extent of a sub activation of the impaired hemisphere (e.g. spatial distribution, timing, synchronization and quality). It is believed that in addition to damaged neurons which cause sub activation of the injured region, the intact hemisphere inhibits the impaired hemisphere. In some case, the laterality index increases as lesion severity increases.
  • BPI data are used in conjunction with results of one or more additional tests that evaluate a subjects abilities in the impaired domain (e.g. Fugel- Mayer (FM) Test and/or Jebsen-Taylor
  • JTT Hand Function Test
  • a computer automatically evaluates data.
  • data from an independent Brain Imaging device and/or BPI data and/or scores from a relevant test are evaluated by a computer.
  • analytic circuitry e.g. programmed with a diagnostic software module receives the data as an input and provides a list of relevant tasks as an output.
  • evaluation of brain function is repeated periodically throughout a recommended therapy regimen.
  • evaluation of brain function is used as an indicator of patient response to therapy.
  • data on patient response to therapy is useful in adjusting a recommended therapy regimen for an individual subject and/or for adjusting therapy recommendations for a population of subjects with similar brain injuries and/or medical histories (e.g. it may be discovered that patients under age 16 respond better to a larger number of shorter therapy sessions or that female patients respond better to a slightly higher delivered current than male patients (or the opposite)).
  • the learning process is progressive and can be divided into stages, with each stage characterized by a pattern of brain activity related to activation and inactivation of certain brain areas.
  • stage specific patterns are identified by external sensors mounted in the helmet (e.g. EEG or NIRS) or independent of the helmet (fMRI).
  • each stage of the learning process can be further characterized in terms of a set of exercise and/or application profile adapted to that stage, optionally in order to achieve desired effects.
  • adaptation is based upon one or more parameters including, but not limited to, which exercise are selected, a number of repetitions of each selected exercise, a time period between exercises and/or sessions and an order of the selected exercises.
  • Patient to patient variation is to be anticipated so that learning progress rates can vary even when an experimentally determined "optimum stage specific exercise set" is used as a therapy regimen for an individual patient.
  • BCI is implemented in each phase of the learning process to train the patient to modify their brain activity to conform to predicted brain activity for the next stage of learning.
  • phases of the learning process are defined by specific activity maps (e.g. the motor region will be divided to sub regions, and stage specific patterns determine which regions are activated to form a stage specific activity map).
  • understanding of the phases of the learning process contributes to an ability to implement a therapy program that aids a patient in progressing to a next phase.
  • these general principles of learning are applied to activities of daily life (ADL).
  • ADL training employs a guiding program including exercises and/or tasks relevant to their personal environment (e.g. their chair, their bed, their door, their cup, their staircase) as opposed to generic ADL components typically encountered in a physical therapy gymnasium of a clinic.
  • portability of the helmet contributes to the success of an ADL based therapy program by allowing the patient to implement exercises in their own personal environment (e.g. home and/or workplace and/or school) with the aid of helmet mediated feedback.
  • a determination of BPI comprises a comparison between brain activity at multiple time points (e.g. before and after the treatment).
  • brain activity is measured during a same exemplary exercise.
  • BPI represents a quantitative measure of change(s) caused by the treatment.
  • a BPI measurement can be made using EEG, MRI, TMS, NIRS, PET or other known technologies for measuring brain function.
  • BPI is based upon a pair of measurements (e.g. measurements performed before and after the first session or before and after a specified number of sessions).
  • time intervals between measurements are shortened and a measurement is made before and after each exercise.
  • evaluation of BPI for each exercise contributes to an ability to gauge an immediate effect of each task on neuronal activity and/or short term trends as a result of the treatment.
  • the temporal and or therapeutic difference which can be expected to produce a significant BPI measure can vary, for example, with one or more of sensitivity of the measurement technique, the therapy program and patient condition.
  • BPI is based upon a series of measurements (e.g. at the end of each therapy session, weekly, monthly or quarterly).
  • the series is divided into pairs of measurements as above.
  • a progress graph for each of the above parameters or total BPI is prepared from the series of measurements.
  • BPI optionally considers one or more parameters selected from among: amplitudes of signals measured in one or more injured portions of the brain, areas involved in activation and a difference in activation between the ipsilesional and the contralesional portions of the brain.
  • measure of motor function can serve as indirect BPI parameters. Measures of motor function include, but are not limited to, range of motion, applied force, rate of motion and smoothness of motion.
  • these parameters are measured while moving a paretic organ (e.g. arm or leg), a healthy organ, and both organs concurrently, optionally simultaneously (e.g. during task performance and/or stimulation and/or guided imagination)
  • activation of a contralesional part of the brain is measured while moving a paretic organ (e.g. before and after the treatment).
  • exemplary duration of response- adaptation for repetitive stimuli/motions EEG
  • EEG EEG
  • negativity of CNV can serve as a parameter.
  • CNV indicates readiness potential or the intention of executing the motion).
  • CNV is measured in damaged brain tissue, and healthy brain tissue while executing movements of the paretic and intact organs. The difference between the measurements serves as an EEG specific BPI parameter.
  • spectral density analysis of EEG patterns can serve as a BPI parameter.
  • analysis of the typical frequencies for mu- rhythm/SCP can be informative.
  • differences between before and after the treatment, between the injured and healthy brain portions, and a ratio between "interesting" frequencies and the background noise can serve as BPI parameters.
  • analysis of spectral density focuses on specific frequencies of interest and/or their intensities relative to other frequencies. For example, a specific wave (e.g. beta wave) can be analyzed with respect to its energy before and after a treatment.
  • BPI measurements based upon one or more parameters as described above are performed as a patient imagines or visualizes performing a task (e.g. elbow flex or forearm extension) as opposed to actually performing the task.
  • a task e.g. elbow flex or forearm extension
  • a same patient is evaluated with respect to an imagination BPI and a performance BPI.
  • BPI data is evaluated and/or plotted separately for each learning stage.
  • learning-stage-specific evaluations and/or plots reveal one or more of slope of improvement, time to reach plateau, time duration of each stage.
  • calculating a slope of improvement in each stage contributes to an ability to evaluate when a specific task has a reduced, optionally no, marginal utility for additional repetitions.
  • the task is modified or switched for a different task at this stage.
  • comparison of BPI plotted as a function of time for similar patient populations treated with different therapy regimens serves as a tool for evaluating the therapy regimens.
  • data of this type from a large group of patients serves as a population data set which contributes to an ability to design a therapy program for similar individuals.
  • BPI plotted as a function of time indicates a learning rate for each stage of learning and/or for each patient and/or for a group of patients in a similar clinical situation.
  • a single parameter in which there a significant improvement is selected as a clinically relevant indicator of BPI.
  • one or more parameters are excluded when evaluating BPI because they are deemed non-informative.
  • a non- informative parameter is one that is inconsistent with other parameters. For example, activation of different brain regions correlates with an increased total signal amplitude because more neurons are activated. However, a decrease in signal to noise ratio for important frequencies suggests the added neurons are activated with no synchrony.
  • clinical relevance of direct measurements of BPI is evaluated by examining a degree of correlation to motor function improvement.
  • medication is administerd systemically and/or locally to affect one or more of brain plasticity, excitation level and blood flow.
  • stimulation at least partially offsets side effect of medication and/or fatigue.
  • stimulation of the brain which produces patterns of brain activity characteristic of an advanced stage of learning suggest that an improvement in motor function is imminent. Possibly, the patient does not perceive any change at this stage and may become frustrated.
  • a BCI which provides positive feedback can contribute to a decrease in patient frustration.
  • evaluation of the effect of stimulation on cortical reorganization and motor improvement for the specific patient considers increases in appropriate neural activity and/or synchronization thereof, during stimulation and/or improvements in motor performance during stimulation and/or a time duration of improvements after the end of the stimulation.
  • a comprehensive evaluation of patient progress logs the entire treatment course.
  • the log may include, for example types of exercises, number of repetitions for each exercise, stimulation durations., L2007/000664
  • sEMG is measured during the treatment period and a graph of electrical activity of the muscles in the paretic limb is used as an indicator of treatment progress and/or BPI.
  • a patient is presented with visual stimuli as an integral part of therapy, for example on display screen 114 (Fig. 1).
  • adjunct visual stimuli are presented before and/or during and/or after performance of a task.
  • visual stimuli are presented at intervals throughout a therapy session.
  • Visual stimuli can be, for example, animation and/or video sequences which are referred to herein as "movies”.
  • the adjunct visual stimulus comprises a movie of someone performing a same task that the patient is being asked to perform (e.g. "touch the shoulder with your right hand”.
  • display screen e.g. "touch the shoulder with your right hand”.
  • the 114 displays only the relevant organ (no face), so that the patient identifies with the presented image.
  • the sequences are custom tailored to an individual patient (e.g. by showing the patient's body part instead of a generic body part).
  • the movie illustrates a correct way (optionally at actual speed or in slow motion) of performing the task and/or provides instructions for correct execution.
  • Instructions can be provided as audio instructions, text instructions or graphic instructions (e.g. arrows superimposed over a portion of the image in the movie).
  • implanted electrodes are activated in a manner that causes nbrain activity corresponding to motion.
  • patient performance is monitored during the task (e.g. by sEMG and/or by motion sensors 108).
  • monitoring data is evaluated by a software module after one or more repetitions of a specific task.
  • the patient is shown a movie with specific instructions for one or more corrections based upon the evaluation.
  • the tasks are associated with ADL (e.g. take the cup with both hands and bring it to your mouth).
  • the movie is personalized so that the patient sees a coffee cup made by their own grandchild positioned on their own kitchen table in the movie.
  • the movie is provided as an interactive game.
  • an input in the form of patient movement e.g. a button press, mouse click or joystick movement
  • produces an output on display screen 114 e.g. firing of a simulated weapon, movement of an animated figure or object or selection of an item.
  • this type of movie is employed for guided imagination.
  • movies are adapted to guide the patient through a desired task.
  • a speech rehabilitation therapy which offers primary audio stimulus in the form a spoken word or phrase offers adjunct visual stimuli in the form of a movie depicting movements of the mouth associated with correct pronunciation.
  • the patient's actual pronunciation is recorded using camera 116 and/or microphone 117.
  • the recording of actual pronunciation is played back, optionally after filtering, for the patient and/or monitored by therapy personnel.
  • a software module offers playback of corrected pronunciation in the patient's voice and/or corrected images of the patient's mouth during pronunciation.
  • the patient can be aware of the correction or unaware of the correction.
  • the movie is subject to input from a BCI.
  • brain activity corresponding to concentration or attention is measured and if concentration diminishes, the movie stops.
  • attention is refocused on display screen 114 (as indicated by brain activity measurements)
  • the movie resumes.
  • BCI provides positive reinforcements for desirable brain activity (e.g. positive visual images or music).
  • a level of detail in the movie can be adjusted in response to measured concentration or attention.
  • the movie is designed to evoke a strong emotion (e.g. by depicting a life threatening situation such as fire, flood, danger of falling or a dangerous animal). Depiction of a life threatening situation in the movie can trigger survival instincts and/or physiochemical responses which can influence brain activity.
  • the movie scenario makes it clear that the patient can escape the life threatening situation by performing a simple act.
  • instructions concerning the simple act are explicitly provided.
  • the simple act can comprises a motor act (e.g. press a button or move a joystick) or a neural activity.
  • a neural motor activity as the simple act is mediated by a BCI which translates a target neural activity in the patient's brain to a life saving sequence in the movie (e.g. opening of a parachute to stop a fall or descent in fire stairs to escape a fire).
  • tasks are adapted to encourage creativity and/or concentration.
  • Exemplary creativity/concentration tasks employ a musical instrument (e.g. xylophone or keyboard) as an input device.
  • a software module provides a sequence of musical notes via speakers and the task is to repeat the sequence of notes using the input device. As a number of notes in the sequence increases, a degree of concentration required for successful completion of the task increases.
  • stimulation provided through the helmet can supplement concentration when a level of difficulty of the presented task in conjunction with the instantaneous concentration and/or attention levels prevents success.
  • similar principles are applicable to non musical tasks.
  • a software module provides a sequence of musical notes with a pattern via speakers and the task is to continue the pattern using the input device.
  • stimulation provided through the helmet can supplement creativity when a level of difficulty of the presented tasks prevents success.
  • similar principles are applicable to non musical tasks.
  • Exemplary psychological treatment In an exemplary embodiment of the invention, the helmet is used as part of a psychological treatment program.
  • movies presented on display 114 are part of the program.
  • the psychological treatment program treats a specific anxiety or phobia and the movies comprise an anxiety stimulus.
  • a patient with agoraphobia might be presented with a movie simulating a walk through an open field.
  • sensors located in the helmet monitor neural activity associated with anxiety or panic caused by the movie.
  • neural stimulation provided by the helmet adjusts neuronal activity to offset the feelings of anxiety.
  • a BCI is used to train the patient to reduce the neural activity underlying anxiety.
  • stimulation is reduced over time as the patient learns to down regulate the neural activity underlying the anxiety.
  • the patient can use the (portable) helmet to deal with an actual anxiety stimulus (e.g. a real walk in the park), instead of a movie stimulation of the anxiety stimulus.
  • presentation of the anxiety stimulus in the movie can be gradual and/or systematic.
  • An additional exemplary embodiment of a psychological treatment programs which can be implemented using the helmet is substance abuse treatment.
  • Substance abuse treatment can be affected, for example, using a modified aversion therapy.
  • a modified aversion therapy For example, an alcoholic patient might be shown a movie of people drinking in a tavern.
  • sensors located in the helmet monitor neural activity associated with a desire for a drink.
  • neural stimulation provided by the helmet can be patterned to adjust neuronal activity to offset desire.
  • the patient can use the (portable) helmet for a real visit to a tavern.
  • substance abuse treatment can be affected using satisfaction therapy.
  • a cocaine addict might be given a measured amount of cocaine in a controlled setting while wearing the helmet.
  • sensors located in the helmet monitor neural activity associated with (1) a feeling of satiety induced by the cocaine initially and (2) a desire for additional cocaine after the feeling of satiety passes.
  • neural stimulation provided by the helmet can be patterned to adjust neuronal activity to emulate satiety and/or to offset desire.
  • a stimulation pattern which effectively emulate satiety and/or to offset desire the patient can use the helmet overcome their addiction.
  • Implementation of devices, methods and systems according to exemplary embodiments of the invention involves performing or completing selected tasks or steps manually, automatically, or a combination thereof.
  • automated performance relies on analytic circuitry.
  • several selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof.
  • selected steps of the invention could be implemented as a chip or a circuit.
  • selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system.
  • selected steps of exemplary embodiments of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.
  • analytic circuitry can comprise a computer such as a PC, laptop computer or personal digital assistant and/or be incorporated into another device (e.g. a cellular telephone or MP 3 player).
  • the computer performs the functions of helmet controller 216 as described above.
  • Exemplary interfaces
  • helmet controller 216 is provided as a computer with one or more relevant software modules installed and a plurality of ports.
  • helmet 106 and/or controller 203 and/or measuring devices 213 and/or 218 and/or camera 116 and/or 215 are connectable to the ports via a suitable connection interface.
  • the ports comprise USB ports and hardware components are connectable to the ports via a USB plug.
  • some hardware components communicate with controller 216 via a wireless interface (e.g. Bluetooth) which fulfils the port function.
  • a wireless interface e.g. Bluetooth
  • Peripheral devices include, but are not limited to, peripheral sensors (e.g. sEMG recorder 218, button 204, controller 203 and peripheral activity monitor module 220) and FES stimulation module 222.
  • exemplary two tiered system e.g. sEMG recorder 218, button 204, controller 203 and peripheral activity monitor module 220.
  • Fig. 10 depicts an exemplary two tiered system 1000 according to one exemplary embodiment of the invention.
  • a first tier (depicted above the dashed line) represents an initial clinical evaluation (e.g. by a neurologist) conducted using a neurologist platform 1010 which receives data from a diagnostic chair 1020.
  • Chair 1020 can be, for example, as depicted in Fig. 1 or Fig. 7 and/or can include a helmet of one of the types depicted in Figs. 1, 3, 4, 5, 6A, 6B or 7 and described hereinabove.
  • the diagnostic chair 1020 includes a large number (e.g., at least 32) of sensors of brain activity and/or sensors placed in close proximity to one another over a particular brain region of interest. Brain activity data from the sensors is relayed to neurologist platform 1010, optionally via a wireless link 1014.
  • the sensors collect data during performance of one or more tasks by the patient as described hereinabove.
  • neurologist platform 1010 uses one or more software modules to analyze the data from the sensors (e.g., to calculate a BPI as described hereinabove).
  • data can be sorted by brain area and/or task type and/or injury state (e.g. contralateral comparison) and/or presence/absence of external stimulation.
  • the neurologist recommends a therapy program, optionally to be implemented without direct supervision by the neurologist (e.g. at home).
  • the portion of Fig. 10 below the line depicts an exemplary therapy program and optional hardware for implementation.
  • the therapy program employs some, or all, of the equipment depicted in/described in the context of the initial clinical evaluation.
  • the therapy program centers around a helmet 1050 with stimulation electrodes and/or sensors 1052 (e.g. as depicted in Figs. 1, 3, 4, 5, 6A, 6B or 7 and described hereinabove) and a controller 1100.
  • controller 1100 and helmet 1050 are configured for wireless communication (e.g. via Bluetooth) as depicted.
  • controller 1100 communicates with and/or is incorporated into a user workstation 1040.
  • the controller is adapted to receive user input from one or more of a mouse 1410, a joystick 1420, a pinch and grip device 1430, a robot 1300 and/or other motor devices 1440 (e.g.
  • the controller is adapted to provide motor input to the user (e.g. via robot 1300 and/or joystick 1420).
  • the motor input is a feedback provided in response to brain activity detected by sensors in helmet 1050 as described above.
  • controller 1100 receives peripheral inputs (e.g. from sEMG 1500 and/or motion sensors 1510 and/or physiologic sensors 1520 (e.g. heart rate and/or respiration and/or temperature monitors) and/or other sensors 1530 (e.g. voice sensors and/or pain sensors).
  • peripheral inputs e.g. from sEMG 1500 and/or motion sensors 1510 and/or physiologic sensors 1520 (e.g. heart rate and/or respiration and/or temperature monitors) and/or other sensors 1530 (e.g. voice sensors and/or pain sensors).
  • Other devices 1200 are also attached to the controller.
  • Other devices 1200 can include, but are not limited to activities of daily living (ADL) props (e.g., cup, plate, flatware), audio outputs (e.g., speakers or earphones), a camera to record task performance, a reflexology device, analgesic aid (e.g., a heating or cooling device or medication delivery pump) and a contraction device.
  • ADL daily living
  • contraction devices are employed to activate muscles and/or increase blood flow.
  • motor training is used for enhancing the control of muscles by athletes.
  • motor training is used for enhancing motor control of musicians.
  • musical feedback is provided during training and corresponding to the exercises.
  • some methods of the present invention find particular utility in rehabilitation, especially when motor control is weak, patchy and/or non-existent.
  • robots and positioning devices e.g., hexapods
  • various ones of the statements described herein may be adapted for such robots and/or positioning devices, in accordance with exemplary embodiments of the invention.
  • software may be provided for such robots and devices for carrying out various of the methods described herein, all in accordance with exemplary embodiments of the invention.
  • the systems described herein are used for uses other than motor rehabilitation, for example, cognitive rehabilitation, task training, testing and/or robotic manipulation.
  • features used to describe a method can be used to characterize an apparatus and features used to describe an apparatus can be used to characterize a method.
  • kits which include sets of a device, one or more limb holding attachments and/or software. Also, within the scope is hardware, software and computer readable-media including such software which is used for carrying out and/or guiding the steps described herein, such as control of arm position and providing feedback.

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Abstract

L'invention concerne une gestion de réhabilitation, qui consiste pour une pluralité de patients pourvus de capteurs, à se voir attribuer des tâches par un thérapeute, à réhabiliter ces patients qui ne font pas directement l'objet d'une attention du thérapeute et à surveiller cette réhabilitation au moyen de données acquises par les capteurs pendant la réalisation des tâches.
PCT/IL2007/000664 2006-06-01 2007-05-31 Stimulation et réhabilitation du cerveau WO2007138598A2 (fr)

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