WO2015024945A1

WO2015024945A1 - Systems and methods for electrotherapy combined with feedback from sensors

Info

Publication number: WO2015024945A1
Application number: PCT/EP2014/067681
Authority: WO
Inventors: Raymond WATT; Jaen Frederik Labuschagne
Original assignee: The Thinker Ag
Priority date: 2013-08-19
Filing date: 2014-08-19
Publication date: 2015-02-26

Abstract

The present invention provides a method for altering the application of an electrotherapy treatment during the treatment, comprising: providing a first electrotherapy to a user via an electrotherapy generator; measuring sensory data related to said user via a sensor during said first electrotherapy; and altering said first electrotherapy to a second electrotherapy based on said sensory data. The present invention also provides a corresponding system. The present invention further provides a method for treating and monitoring a patient with traumatic brain injury (TBI), comprising: providing a device having an audio output and an electro-encephalograph (EEG) data management program; providing an electrotherapy generator for delivering an electrotherapy to said patient; and providing an EEG measurement system for measuring electrical activity of said patient's brain; wherein the EEG measurement system is configured to attach EEG sensor electrodes to a user's body; to collect EEG data on said user, to store said EEG data, and to make said EEG data available to said EEG management program operative in the device. The present invention also provides a corresponding system.

Description

SYSTEMS AND METHODS FOR ELECTROTHERAPY COMBINED WITH FEEDBACK

FROM SENSORS

TECHNICAL FIELD

[001] This invention relates to systems and methods for electrotherapy combined with feedback from sensors.

BACKGROUND

[002] Noninvasive Electrical Brain Stimulation (herein referred to as NIEBS) applies gentle micro-current pulses to the brain using electrodes. It is widely accepted that NIEBS stimulates the brain to manufacture neurotransmitters. Noninvasive electrical brain stimulation has also been proposed for treatment of various medical conditions.

[003] The signals operate to normalize the electrical output of the brain. NIEBS has thus been used/tested to treat substance dependence, depression and anxiety. It has been noted in at least some instances that NIEBS has equal or greater efficacy for the treatment of depression when compared to antidepressant medications, with fewer side effects.

[004] The mechanism by which NIEBS produces its effects is not yet fully

understood. It is postulated that the stimulation of brain tissue causes increased amounts of neurotransmitters to be released, specifically serotonin, beta endorphin, and noradrenaline. It is believed that these neurotransmitters in turn permit a return to normal biochemical homeostasis of the limbic system of the brain that may have been imbalanced by a stress-related condition.

SUMMARY

In a first aspect, the present invention provides a method for altering the application of an electrotherapy treatment during the treatment, comprising:

providing a first electrotherapy to a user via an electrotherapy generator; measuring sensory data related to said user via a sensor during said first electrotherapy; and

altering said first electrotherapy to a second electrotherapy based on said sensory data.

In a second aspect, the present invention provides a system for altering the application of an electrotherapy treatment during the treatment, comprising:

an electrotherapy generator for providing a first electrotherapy to a user;

a sensor for measuring sensory data related to said user during said first electrotherapy; and

a processor for altering said first electrotherapy to a second electrotherapy based on said sensory data.

In a third aspect, the present invention provides a method for treating and monitoring a patient with traumatic brain injury (TBI), comprising:

providing a device having an audio output and an electro-encephalograph (EEG) data management program;

providing an electrotherapy generator for delivering an electrotherapy to said patient; and

providing an EEG measurement system for measuring electrical activity of said patient's brain;

wherein the EEG measurement system is configured to attach EEG sensor electrodes to a user's body; to collect EEG data on said user, to store said EEG data, and to make said EEG data available to said EEG management program operative in the device.

In a fourth aspect, the present invention provides a system for treating and monitoring a patient with traumatic brain injury (TBI), comprising:

a device having an audio output and an electro-encephalograph (EEG) data management program;

an electrotherapy generator for delivering an electrotherapy to said patient; and an EEG measurement system for measuring electrical activity of said patient's brain;

BRIEF DESCRIPTION OF THE DRAWINGS

[005] Figure 1 illustrates block diagrams of example waveforms for use in a noninvasive electrical brain stimulation system in accordance with embodiments of the present technology.

[006] Figure 2A illustrates a block diagram of an example environment in accordance with embodiments of the present technology and shows sensory feedback for alteration of electrotherapy treatment.

[007] Figure 2B illustrates a block diagram of an example environment in accordance with embodiments of the present technology.

[008] Figure 2C illustrates an example abnormal EEG reading in accordance with embodiments of the present technology.

[009] The drawings referred to in this description of embodiments should be understood as not being drawn to scale except if specifically noted.

DETAILED DESCRIPTION

[0010] Reference will now be made in detail to embodiments of the present technology, examples of which are illustrated in the accompanying drawings. While the technology will be described in conjunction with various embodiment(s), it will be understood that they are not intended to limit the present technology to these embodiments. On the contrary, the present technology is intended to cover

alternatives, modifications and equivalents, which may be included within the scope of the various embodiments as defined by the appended claims.

[0011] Furthermore, in the following description of embodiments, numerous specific details are set forth in order to provide a thorough understanding of the present technology. However, the present technology may be practiced without these specific details. In other instances, well known methods, procedures, components, and circuits have not been described in detail as not to unnecessarily obscure aspects of the present embodiments.

Overview of Systems and Methods for Electrotherapy Combined with Feedback from

Sensors

[0012] Embodiments of the present technology are for systems and methods for electrotherapy with combined feedback from sensors. The feedback from the sensors may be employed to alter the electrotherapy. The description and claims herein specifically describe noninvasive electrical brain stimulation (NIEBS). However, the present technology applies generally to electrotherapy and electro medicine in its many forms. Therefore, the descriptions and claims related to NIEBS may be extended to include electrotherapy in general. Types of electrotherapy may be for, but are not limited to, electro neurostimulation, electro neuromodulation, neuromodulation, brain stimulation, electro medicine, bone growth, muscle stimulation, pain management, stimulation of the vagus nerve, etc. [0013] For example, neurostimulation involves modulation of the nervous system and electrically activate neurons in the body. The activation of neural elements in a part of the nervous system can be effectively facilitated by stimulation. Micro-electrodes are utilized to interface with excitable tissue in order to either restore recording experiences to the implant recipient or control an effector organ. Additionally, neuromodulation is the physiological process by which a given neuron uses several different neurotransmitters to regulate diverse populations of central nervous system neurons. This is in contrast to classical synaptic transmission, in which one presynaptic neuron directly influences a single postsynaptic partner. Neuromodulators secreted by a small group of neurons diffuse through large areas of the nervous system, affecting multiple neurons. Examples of neuromodulators include dopamine, serotonin, acetylcholine, histamine and others.

[0014] Noninvasive electrical brain stimulation (NIEBS) is a treatment that applies pulses to the brain across the head of the patient using electrodes. There are many types of NIEBS such as transcranial direct current stimulation (tDCS) which is a form of neuro-stimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. There are three different types of tDCS: anodal, cathodal, and sham. The anodal stimulation is positive (V+) stimulation that increases the neuronal excitability of the area being stimulated. Cathodal (V-) stimulation decreases the neuronal excitability of the area being stimulated. Cathodal stimulation can treat psychological disorders that are caused by the hyper-activity of an area of the brain. Sham stimulation is used as a control in experiments. Sham stimulation emits a brief current but then remains off for the remainder of the stimulation time. With sham stimulation, the person receiving the tDCS does not know that they are not receiving prolonged stimulation.

[0015] Another form of NIEBS is transcranial alternating current stimulation (tACS) which is a noninvasive means by which alternating currents applied through the skull over the occipital cortex of the brain entrains in a frequency-specific fashion the neural oscillations of the underlying brain. Another class of NIEBS is transcranial pulsed current stimulation (tPCS). [0016] tPCS is a noninvasive method that employs a waveform for use in NIEBS. A tPCS generator is a self-powered device that implements either a fixed tPCS therapy program with preset parameters, or a programmable device that can receive a tPCS therapy program based on treatment options determined by a healthcare professional to be of use to a person with a specific condition. tPCS may also employ a chaotic system that varies many of the pulse characteristics in a random, non-repetitive process.

[0017] Transcranial magnetic stimulation (TMS) is a noninvasive method to cause depolarization or hyperpolarization in the neurons of the brain. TMS uses

electromagnetic induction to induce weak electric currents using a rapidly changing magnetic field; this can cause activity in specific or general parts of the brain with minimal discomfort, allowing the functioning and interconnections of the brain to be studied. A variant of TMS is repetitive transcranial magnetic stimulation (rTMS).

[0018] The present technology is not limited to one form of NIEBS. Therefore, as used herein, NIEBS may refer to many varieties of NIEBS including tDCS, tACS, tPCS, TMS, rTMS, and any other neuro-stimulation type protocols such as random noise stimulation and chaotic noise stimulation.

[0019] NIEBS involves brain stimulation by low current low voltage that may use alternating square waves or other waves. The effect is to improve the brain's

"plasticity," making it easier to learn. The effect may also be described as an increase in focus, getting into the flow, or being in the zone.

[0020] The electrodes of the present technology may be attached to a user's body at any number of locations. For example, for NIEBS, the electrodes are typically attached to the skin of the user's head and may be attached to the ears, earlobes, back of the skull, forehead, cheeks, etc. However, for both electrotherapy and NIEBS in general the electrodes may attached anywhere on the body such as to fingers, the arms, legs, torso, head, etc. The hardware may also include speakers such as headphones. The speakers may be separate from the electrodes or may be combined with the electrodes in the same frame or housing.

[0021] The present technology employs feedback from sensors during the

electrotherapy such that the electrotherapy may be changed on the fly based on feedback from the sensors. For example, the sensors may be electroencephalography (EEG) sensors or a heart rate monitor. The electrotherapy or NIEBS is generated by an electrotherapy generator that may have a microprocessor. During the electrotherapy treatment, data is recorded regarding the patient via the sensors. The sensory data may be regarded as feedback for the electrotherapy and is then used to alter or change the application of electrotherapy. The decision to alter or change the electrotherapy based on the sensory data or feedback may be made by an automated process associated with a processor and algorithms. The processor may be the microprocessor associated with the electrotherapy generator or another processor independent of the electrotherapy generator. Such altering and changing of the electrotherapy during treatment is useful to treat various medical disorders, diseases, ailments, etc. including, but not limited to, traumatic brain injuries.

[0022] Descriptions of preferred embodiments in relation to the first and second aspects of the invention are applicable to the third and fourth aspects of the invention, unless technically inconsistent or otherwise stated.

Embodiments for Systems and Methods for Electrotherapy Combined with Feedback from Sensors

[0023] The first and second aspects of the invention relate to a method and system respectively for altering the application of an electrotherapy treatment during the treatment.

[0024] With reference to Fig. 2A which depicts hardware in an environment for using feedback from sensors to alter the application of electrotherapy treatment on the fly during the treatment. The user or patient may be a human user that is employing electrotherapy or electro medicine under their own direction or under the direction of a healthcare professional. The electrotherapy may or may not be accomplished in a clinical setting. The electrotherapy generator is for generating electrotherapy signals used to apply electrotherapy to the user via electrodes. It should be appreciated that any number of electrodes may be employed. The electrotherapy application may be begin based on a preprogrammed application. For example, the preprogrammed application may be based on waveforms stored in a memory associated with the electrotherapy generator. The memory for the electrotherapy generator may store a variety of waveforms and electrotherapy programs which may be changed via data or network connections. The memory may be removable or the electrotherapy generator may be connected to another device via a data port wired or wireless. For example, the electrotherapy generator may be controlled by the optional processor which is part of a larger computer system.

[0025] In one embodiment, the electrotherapy generator is a self-contained device with its own power source such as batteries. In one embodiment, the electrotherapy generator draws power from a second independent device. The second independent device may be the optional processor. The optional processor may be a handheld device such as a smart phone or may be a computer system such as a laptop or desktop computer.

[0026] The sensor represented by the sensor in Fig. 2A may refer to a single sensor or a plurality of sensors. The sensors are attached to the patient and generate data regarding the patient. The data may be collected and stored by components of the sensor or may be sent directly to the electrotherapy generator or the optional processor. The sensor may be, but is not limited to, an electroencephalography (EEG) sensor, sensors for an electrocardiogram (EKG or ECG), heart rate monitors, pulse rate, blood pressure monitors, sonar sensors, sensors for echocardiograms, temperature of the body, or other sensors used to measure data related to a body such as vital signs. In one embodiment, a plurality of different types of sensors are used in combination. For example, an EEG sensor may be used with a skin temperature sensor to provide feedback for the electrotherapy. Other combinations not specifically described herein may also be employed. Two or three sensors may be employed or any number of sensors may be employed during the electrotherapy and data from any number of sensors may be employed to change the electrotherapy on the fly based on feedback from the sensors. In one embodiment, the first or second electrotherapy includes stimulation of the vagus nerve also called the pneumogastric nerve and cranial nerve X. The vagus nerve is the tenth of twelve (excluding CNO) paired cranial nerves.

[0027] In one embodiment, the sensor is a Holter monitor for ambulatory ECG readings. The Holter monitor is used to monitor heart condition and may be able to be processed locally, such as in a cell phone, to produce data. In one embodiment, the sensor is able to measure arrhythmias. Other devices may also be employed in combination with or interface with a smart phone that act as sensors to monitor and generate data regarding a patient. For example, a glucose monitor may couple with or attach to a smart phone and the patient is able to place a test strip with a drop of blood into the glucose monitor to calculate glucose levels in the patient.

[0028] In one embodiment, the sensor may be a medical device permanently implanted or associated with a patient that is able to generate data regarding the patient. For example, a pacemaker may be implanted in a patient and generates data that may be wirelessly communicated to provide feedback for the electrotherapy. In another example an insulin pump or a glucose monitor associated with a patient may be used as the sensor.

[0029] The data measured and collected from the sensor is considered feedback from the body and may be feedback for how the electrotherapy is being received by the body of the user. The feedback data may then be used to change or alter the application of the electrotherapy on the fly, in other words altering a first electrotherapy to a second electrotherapy. The change or alteration may be a change in a wave pattern used to generate the signal for the electrotherapy or it may be a change from one type of electrotherapy to a different type of electrotherapy. In one embodiment, the first or second electrotherapy is NIEBS. In one embodiment, the alteration or change is calculated and performed by the electrotherapy generator using a microprocessor. For example, the electrotherapy generator may have a processor or microprocessor as a component of the generator. In one embodiment, the alteration of change is calculated by the optional processor independent of the electrotherapy generator. In such an instance, the optional processor must know the current electrotherapy being applied to the user. Such information may be sent to the optional processor by the electrotherapy generator. The optional processor may control the electrotherapy generator.

[0030] The alteration of the electrotherapy on the fly may be an automated process. Algorithms may be employed to alter the electrotherapy application. For example, data tables may be created and used to look up known solutions based on the data from the sensory feedback. In one embodiment, the process is not automated and instead presents the sensory feedback data to a person such as a healthcare professional and the process receives the adjustments from the person. The various components shown in Fig. 2A may be remote to one another. For example, the user, the sensor, and the electrotherapy generator may be located in a first location while the optional processor is located in a second location remote to the first location and communicates with the other components over a network such as the Internet or a cellular network.

NIEBS and Traumatic Brain Injury (TBI)

[0031] Studies show the benefits of NIEBS for TBI. Coma patients, patients with severe learning disabilities, etc. have all been shown to be positively affected by brain stimulation. What makes TBI's a bit different, is that their NIEBS-application (dose or treatment) is modulated on their specific electroencephalography (EEG). Specifically the measure of EEG means measure the voltage fluctuations resulting from ionic current flows within the neurons of the brain. NIEBS can therefore be used in combination with monitoring EEG to treat and monitor a patient with TBI.

[0032] Accordingly, the third and fourth aspects of the invention relate to a method and system respectively for treating and monitoring a patient with TBI. In some embodiments, the method and system of the third and fourth aspects of the invention are a method and system for monitoring a patient with TBI. Although these aspects of the invention will now be described in relation to NIEBS, it will be understood that the method and system of the third and fourth aspects of the invention are applicable to electrotherapy in general.

[0033] With reference to Fig. 2B which depicts hardware in an environment for using NIEBS and EEG to treat TBI's. User 701 is depicted as associated with device 732 which may be a smart phone, cell phone, a PDA, a digital music player or other device. Device 732 may be a handheld device or part of a larger device. Device 732 includes a processor, ROM, RAM, battery or other power source, display, controls, and audio output port. Device 732 is depicted as including components that may or may not be part of device 732 such as a phone, a program NIEBS generator, a NIEBS controller, an EEG manager, and a power tune. For example, program NIEBS generator and NIEBS controller may be a separate hardware device as depicted and described elsewhere in this disclosure. The separate hardware device may also comprise the EEG manager.

[0034] Fig. 12B also depicts ear piece electrodes and speakers. The electrodes may attach to the skin of the patient anywhere on the body including any portion of the ear. The electrodes may be in pairs and there may be a plurality of pairs of electrodes configured to deliver electrotherapy to the patient. The speakers may be headphones or other speakers for delivering or playing audio sounds such as music. The

electrotherapy may or may not comprise pulses that are caused by the rhythm or beat of the music playing on the speakers. The electrodes and speakers may be combined into one housing or may be separate. Electroencephalography (EEG) sensors may also be applied to user 710 for detecting and the recording of electrical activity of user 701 along the scalp or head. EEG measures voltage fluctuations resulting from ionic current flows within the neurons of the brain. The EEG sensor is associated with an EEG machine such as EEG system 760 including an EEG voltmeter system, data capture, data storage, and microprocessor controller. The EEG machine communicates data to EEG manager which is associated with the NIEBS controller and program NIEBS generator. In one embodiment, the electrodes for NIEBS and the EEG sensor are combined into one unit. In other words, the electrode can deliver pulses for NIEBS while simultaneously measuring EEG. In one embodiment, the EEG sensor and the electrodes for NIEBS are separate. The earpiece speakers, electrodes, and EEG sensors may all be housed in a holder assembly wearable by user 701.

[0035] In one embodiment, the present technology operates to administer NIEBS treatments and measure EEG measurements. Then during the NIEBS treatment, based on the EEG measurements, alter the NIEBS treatment on the fly. This may be accomplished automatically without intervention from someone such as a healthcare professional. The alteration can be carried out as described herein in relation to the first and second aspects of the invention. The alteration may also be based on algorithms used for NIEBS treatments associated with EEG measurements. Moreover, EEG measurements may be stored as the NIEBS treatment is altered such that the results may be studied and the NIEBS treatments may be refined. The refinement may be accomplished via big data techniques and may be accomplished via cloud computing. Therefore, NIEBS treatment alterations may be based on data collected for the instant patient or from other patients or both. Such alteration may be accomplished in real time.

[0036] In one embodiment, the invention provides a method for [automatically and remotely] treating and monitoring a patient with traumatic brain injury, comprising:

providing a device having an audio output and an EEG data manager program; providing a Cranial Electrotherapy Stimulation [NIEBS] generator for delivering a NIEBS therapy stimulation to a user via electrodes in contact with skin in the vicinity of the user's ears;

providing an electro-encephalograph measurement system [EEG] for measuring electrical activity of a user's brain;

wherein the EEG system is configured to attach EEG sensor electrodes to a user's body according to EEG measurement principles; to collect EEG data on said user, to store said EEG data, and to make said EEG data available to said EEG management program operative in the cellphone/pda. [a flowchart].

[0037] In one embodiment the cellphone/pda is configured to deliver EEG data to a remote server via an internet connection.

[0038] In one embodiment the EEG data at the remote server is accessible by brain trauma treatment professionals.

[0039] In one embodiment the audio output from the cellphone/pda is provided to headphones [worn by the user.]

[0040] In one embodiment the NIEBS generator is integrated into the cellphone/pda.

[0041] In one embodiment the NIEBS generator is a stand-alone device and is powered by an audio track [Power Tune] providing inaudible audio to an ac/dc power converter.

[0042] In one embodiment the NIEBS generator is controlled by program in the cellphone/pda.

[0043] In one embodiment the earpiece/speakers and the electrodes are supported in a holder.

[0044] In one embodiment the EEG sensors are supported in a holder.

[0045] With reference to Fig. 2C which depicts an abnormal EEG readings or signals. The abnormal reading of an EEG may be feedback that is used by the present technology to alter the electrotherapy. For example, in Fig. 2C the spikes in the EEG reading may refer to an epileptic seizure being experienced by the patient. [0046] With reference to Fig. 1 which depicts wave forms that may be employed for use with the present technology. A NIEBS or electrotherapy generator may receive wave forms from an audio source or from a waveform synthesizer associated with the NIEBS generator. The NIEBS generator may generate a NIEBS signal with associated wave forms for the NIEBS treatment. Fig. 1 depicts well known square wave forms for use in the present technology. The present technology is not limited to wave forms in Fig. 1 but may also employ other wave forms such as sine waves.

[0047] Wave forms for the present technology may be stored in a library and are used to create pulse patterns or pulse trains for use in NIEBS. The wave forms may be implemented via a programmable D/A converter. Research indicates that different pulse patterns have different effects on the brain, and that some pulse patterns have different effects on various conditions. Therefore, there is a need for a library of different pulse patterns to suit different health conditions.

[0048] The rate of pulses per second refers to a start of positive-going pulse to stop, with the delay until the next positive-going pulse starts. Like a sine wave, regardless of whether or not there is a negative-going pulse. "Beginning of a pulse rising, to the next time the pulse starts rising again." The following are examples of pulse rates that may be employed by the present technology:

[0049] 1. Pulse rate in range of 3 - 5 Hz. Low Freq.

[0050] 2. Pulse rate in range of 50 - 100 Hz. Low Freq.

[0051] 3. Pulse rate in range from 100 - 640 Hz. High Freq.

[0052] 4. Pulse rate in range of 0.1 - 100 Hz

[0053] 5. Direct current

[0054] Current level delivered: 1.5 mA. [milli-Ampere]

[0055] Current density on the skin: safety limit is between 25 and 60 microA/cm² [from Poreisz et al., 2007] The electric field across the brain tissue is on the order of less than 5 mV/mm, or 5 milli-Volts/millimeter. [0056] Pulse pattern may be a Random Noise Stimulation pattern. Good results reported by Fertonani et al in paper "Random Noise Stimulation Improves

Neuroplasticity in Perceptual Learning," The Journal of Neuroscience, October 26, 201 1 31 (43): 15416-15423.

[0057] Noninvasive electrical brain stimulation (herein referred to as NIEBS) applies gentle micro-current pulses to the brain using electrodes. The electrodes of the present technology may be attached to a user's body at any number of locations. For example, for NIEBS, the electrodes are typically attached to the skin of the user's head and may be attached to the ears, earlobes, back of the skull, forehead, cheeks, etc. However, for both electrotherapy and NIEBS in general the electrodes may attached anywhere on the body such as to fingers, the arms, legs, torso, head, etc..

[0058] In NIEBS significant amounts of current pass the skull and reach cortical and subcortical structures. In addition, depending on the montage, induced currents at subcortical areas, such as midbrain, pons, thalamus and hypothalamus are of similar magnitude than that of cortical areas. Incremental variations of electrode position on the head surface also influence which cortical regions are modulated. The high- resolution modeling predictions suggest that details of electrode montage influence current flow through superficial and deep structures. Also, laptop based methods for tPCS dose design using dominant frequency and spherical models. These modeling predictions and tools are the first step to advance rational and optimized use of tPCS and NIEBS.

[0059] It is widely accepted that NIEBS stimulates the brain to manufacture

neurotransmitters, like endorphins, which improve moods, emotions and cognitive capabilities. Noninvasive electrical brain stimulation has also been proposed for treatment following a stroke, brain trauma, high blood pressure, and Alzheimer's disease, as well as any or all neurological disorders, any or all mental disorders, and any or all cognitive enhancements. The present technology may also be used by healthy users or users who are not suffering from any diagnosed disorders or diseases. For example, a healthy user may be a student using the present technology to increase focus and learning abilities or may be an athlete using the present technology to increase sports performance.

[0060] The signals apparently normalize the electrical output of the brain. NIEBS has thus been used or tested to treat substance dependence, depression and anxiety. It has been noted in at least some instances that NIEBS has equal or greater efficacy for the treatment of depression when compared to antidepressant medications, with fewer side effects. NIEBS may be used specifically in combination with anti-depressant drugs and may be used to eliminate the side effects of central nervous system (CNS) medications or drugs in general. NIEBS may also be used in conjunction with other traditional medicine.

[0061] Treatments can be used in association with the present technology in ranges from less than one second up to an infinite number of seconds. The present technology is not limited to a particular range of duration, current, or frequency. The following ranges are meant as examples and do not limit the present technology. In one embodiment, a range is used from 10 to 30 minutes in duration although the treatments may extend up to 11/2 (1.5) hours depending on the electrical current configuration. The currents employed may be applied in pulse form or direct form with a pulse width in the range of from about 1 to about 500 milliseconds (ms) at a frequency of from about 0.1 Hertz (Hz) up to 1000 Hz with the current being less than 1 milliampere (mA) up to 5 mA

[0062] In accordance with an embodiment of the invention there is provided equipment for the implementation of a method as defined above, said equipment comprising a noninvasive electrical brain stimulation pulse generator and associated electrodes for applying pulses generated by the pulse generator to the head of a patient, wherein the equipment includes multiple electrodes.

[0063] In an embodiment of the invention, there is an audio signal player and at least one associated loudspeaker for converting output from the signal player into audible sound. The at least one loudspeaker is preferably a pair of earphones and the noninvasive electrical brain stimulation pulse generator and sound signal generator may be built into a single unit, but are not necessarily thus combined.

[0064] Note that there are the following types of stimulation configurations:

[0065] 1. Positive going pulse, with a direct current average in one direction. Class IA and Class IB deliver a varying amount of direct current in little bursts.

[0066] 2. Alternating current pulses, where the direction of current alternates from positive going to negative going, as in Class IIA and Class MB and IIC and IID. The average may be in one direction predominantly, or may average out to zero if the pulses are symmetric and equal in duration over time. For some modes, there is a net direct current passing through the brain.

[0067] 3. Class III shows a pulse train with a delay between delivery of a series of pulses.

[0068] The next paragraphs discuss how this delay may be configured, and is part of the overall therapy formulation that is available to a medical practitioner.

[0069] 1. Random time period. Use a random number generator with a specified range in seconds. For example, 1 -100 seconds. Run the random number generator which is set to produce a number between 1 and 100. Use that number as the time period between pulses. Run the generator after each pulse to determine the next time delay, or period, from the last pulse.

[0070] 2. Semi-random time period.

[0071] Pick some time periods that are known to have some therapeutic effect. Make a table. For example: [0072] Random No. 1 3 5 10 20 40 60 100.

[0073] Bin containing 1 2 3 4 5 6 7 8

[0074] the delay

[0075] Then randomly select from this group of time periods. Again, use a random number generator whose bounds are the number of allowed states. In the above example, there are 8 possible delay time periods. Set the random number generator to select any of the numbers from 1 to 8. Use the time delay associated with that bin number.

[0076] Say the random number generator picks 4. That means we use 10 second delay as the time period to the next pulse train initiation.

[0077] 3. Periodic but increasing delay, with a plan

[0078] Here the time delay from one pulse train event to the next is arbitrarily set to predetermined sequence. It may be one with a set increase from one period duration to the next. As in 5 10 30 60 repeat 5 10 30 60.

[0079] 4. Periodic, static period

[0080] Set delay to one of the group [ 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10] seconds. Or any other time period from 1 to 300 seconds, for example.

[0081] 5. Continuous pulse train with no delay between any arbitrary group of pulses. Arbitrary duration of such pulse trains, selected from group [1 -1000] seconds.

[0082] 6. Direct Current Stimulation [0083] No pulses, just application of a constant voltage for some time period. One could consider this a special case of a single positive going pulse with a really long time duration.

Notes on using chaotic / random pulse for electrotherapy:

[0084] Pulses or pulse trains for electrotherapy may be patterned or random.

However, the idea of random pulses may not be desirable as random may still indicate a measureable structure impulse. The term chaotic pattern is better description of the pulse referred to herein. Chaotic may also be used to define the variety of the pauses or periods in between pulse trains. The level of chaoticness may be controlled via buttons, sliders, diodes, or other controls associated with the electrotherapy generator.

Computer Implemented Methods

[0085] It should be appreciated that the methods described herein may be computer implemented methods that are carried out by processors and electrical components under the control of computer usable and computer executable instructions. The computer usable and computer executable instructions reside, for example, in data storage features such as computer usable volatile and non-volatile memory. However, the computer usable and computer executable instructions may reside in any type of computer usable storage medium. In one embodiment, the methods may reside in a computer usable storage medium having instructions embodied therein that when executed cause a computer system to perform the method. In one embodiment, the NIEBS or electrotherapy signals described herein are non-transitory but rather are sent over wired connections to the electrodes.

[0086] It is intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that the detailed description should not be used to limit the scope of the invention.

Claims

1. A method for altering the application of an electrotherapy treatment during the treatment, comprising:

providing a first electrotherapy to a user via an electrotherapy generator;

measuring sensory data related to said user via a sensor during said first electrotherapy; and

2. A system for altering the application of an electrotherapy treatment during the treatment, comprising:

an electrotherapy generator for providing a first electrotherapy to a user;

3. The system of Claim 2 wherein said processor is a component of said electrotherapy generator.

4. The system of Claim 2 wherein said processor is a component of hardware device independent of said electrotherapy generator.

5. The method of Claim 1 or the system of any one of Claims 2 to 4 wherein said first or second electrotherapy includes stimulation of the vagus nerve.

6. The method of Claim 1 , the system of any one of Claims 2 to 4 or the method or system of Claim 5 wherein said sensor is selected from the group consisting of an electroencephalography (EEG) sensor, sensors for an electrocardiogram (EKG or ECG), heart rate monitors, pulse rate, blood pressure monitors, sonar sensors, sensors for echocardiograms, temperature of the body, and other sensors used to measure data related to a body such as vital signs.

7. The method or system of Claim 6 wherein said sensor is a Holter monitor, a pacemaker, an insulin monitor or a glucose monitor.

8. A method for treating and monitoring a patient with traumatic brain injury (TBI), comprising:

9. The method of claim 8, further comprising:

providing electrotherapy to said patient via said electrotherapy generator; and measuring electrical activity of said patient's brain using said EEG measurement system.

10. The method of claim 9, further comprising:

altering said electrotherapy to a different electrotherapy based on said EEG data.

1 1. A system for treating and monitoring a patient with traumatic brain injury (TBI), comprising: a device having an audio output and an electro-encephalograph (EEG) data management program;

12. The method of any one of claims 8 to 10 or the system of claim 1 1 wherein the device is a smart phone, a cell phone, a PDA or a digital music player.

13. The method or system of claim 12 wherein the device is configured to deliver the EEG data to a remote server via an internet connection.

13. The method or system of claim 13 wherein the EEG data at the remote server is accessible by brain trauma treatment professionals.

14. The method or system of any one of claims 8 to 13 wherein the audio output from the device is provided to headphones worn by the patient.

15. The method or system of any one of claims 8 to 14 wherein the electrotherapy generator is integrated into the device.

16. The method or system of any one of claims 8 to 14 wherein the electrotherapy generator is a stand-alone device and is powered by an audio track providing inaudible audio to an AC/DC power converter.

17. The method or system of any one of claims 8 to 16 wherein the electrotherapy generator is controlled by program in the device.

18. The method or system of any one of claims 8 to 17 wherein the electrotherapy generator is a NIEBS generator.

19. The method or system of any one of claims 8 to 18 wherein the electrotherapy is delivered to said patient via electrodes in contact with skin in the vicinity of the patient's ears.

20. The method or system of any one of claims 8 to 19 wherein the earpiece/speakers and the electrodes are supported in a holder.

21. The method or system of any one of claims 8 to 20 wherein the EEG sensors are supported in a holder.