WO2018018019A1

WO2018018019A1 - Automated multi-spectra transcranial stimulation device

Info

Publication number: WO2018018019A1
Application number: PCT/US2017/043398
Authority: WO
Inventors: Charles Knezevich; Kevin T. MURPHY
Original assignee: Freqlogic, Inc.
Priority date: 2016-07-22
Filing date: 2017-07-21
Publication date: 2018-01-25

Abstract

Automated Multi-spectra Transcranial Stimulation (AMTS) devices harness sensors and emitters to treat one or more regions of a patient's brain simultaneously. An AMTS includes an integrated collection of miniaturized external brain stimulation emitters that make use of electro-magnetic stimulation, laser light pulses, and RF frequencies in synchronized pulses. The emitters may operate together in a phased-array to target a specific region of the brain. An AMTS device uses sensors to detect brainwave patterns and automatically configure the spectra, amplitude, and duration combinations for multiple emitters to promote coherence and synchronous responses that are measured and documented in real-time. After the emitters stimulate a patient's brain, another sensor is used automatically improve a second treatment session creating a near contemporaneous diagnosis, analysis, treatment, and result cycle.

Description

AUTOMATED MULTI-SPECTRA

TRANSCRANIAL STIMULATION DEVICE

RELATED APPLICATION

[01] The present application claims priority to U.S. provisional patent application no. 62/365,917 filed 22 July 2016, which is incorporated herein by reference in its entirety.

BACKGROUND

[02] Field of the Invention

[03] The present disclosure relates to Automated Multi-spectra Transcranial Stimulation (AMTS) devices generally and more specifically to AMTS devices configured to treat one or more regions of a patient's brain simultaneously.

SUMMARY

[04] AMTS devices harness sensors and emitters to treat one or more regions of a patient's brain simultaneously. An AMTS includes an integrated collection of miniaturized external brain stimulation emitters that make use of electro-magnetic stimulation, laser light pulses, and RF frequencies in synchronized pulses. The emitters may operate together in a phased-array to target a specific region of the brain. An AMTS device uses sensors to detect brainwave patterns and automatically configure the spectra, amplitude, and duration combinations for multiple emitters to promote coherence and synchronous responses that are measured and documented in real-time. After the emitters stimulate a patient's brain, another sensor is used automatically improve a second treatment session creating a near contemporaneous diagnosis, analysis, treatment, and result cycle.

BRIEF DESCRIPTION OF THE DRAWINGS

[05] The specification makes reference to the following appended figures, in which use of like reference numerals in different figures is intended to illustrate like or analogous components.

[06] FIG. 1 is an block diagram of a therapy unit of an automatic multi-spectra transcranial stimulation device according to certain aspects of the present disclosure. [07] FIG. 2 is a block diagram of the cap unit according to certain aspects of the present disclosure.

[08] FIG. 3 is a block diagram of a node according to certain aspects of the present disclosure.

[09] FIG. 4A and 4B illustrate flowcharts of embodiments of a process for operating an automatic multi-spectra transcranial stimulation device.

[10] FIG. 5 illustrates a flowchart of an embodiment of a process for calibrating an automatic multi-spectra transcranial stimulation device.

[11] FIG. 6A, 6B and 6C illustrate flowcharts of embodiments of a process for configuring and operating a node of an automatic multi-spectra transcranial stimulation device.

[12] In the appended figures, similar components and/or features may have the same reference label. Where the reference label is used in the specification, the description is applicable to any one of the similar components having the same reference label.

DETAILED DESCRIPTION

[13] The ensuing description provides preferred exemplary embodiment(s) only, and is not intended to limit the scope, applicability or configuration of the disclosure. Rather, the ensuing description of the preferred exemplary embodiment(s) will provide those skilled in the art with an enabling description for implementing a preferred exemplary embodiment. It is understood that various changes may be made in the function and arrangement of elements without departing from the spirit and scope as set forth in the appended claims.

[14] Certain aspects and features of the present disclosure relate to Automated Multi-spectral Transcranial Stimulation (AMTS) devices configured to treat one more regions of a patient's brain simultaneously. An AMTS device may comprise an integrated collection of miniaturized external brain stimulation tools that make use of electro-magnetic stimulation, laser light pulses, and RF frequencies in synchronized pulses. The AMTS device may use a plurality of nodes that integrate sensors (e.g. a touchless dry electroencephalogram (EEG) sensor) and emitters (e.g. magnetic emitter, a radio frequency (RF) emitter, and/or a laser emitter). In some embodiments, two or more magnetic emitters may, independently or in concert, generate electro-magnetic fields that that are aligned over the targeted regions of a patient's brain. For example, two or more magnetic emitters can operate in a phased-array system such that a primary emitter emits an electromagnetic field that may be stretched, enlarged, or concentrated in shape or depth using the electro-magnetic field generated by a second magnetic emitter. An AMTS device may employ an automatic control system that detects the most effective magnetic, laser, and RF spectra amplitude and duration combinations to promote coherence and synchronous responses, measured and documented in real-time. Between treatments, the AMTS device can use sensors to capture the patient's brainwave pattern in order to more effectively direct the one or more emitters in later treatments. The process may be repeated for a predetermined period of time or until it is detected that the patient's brain is no longer susceptible to treatment.

[15] In some embodiments, one or more emitters can comprise magnetic emitters that are graphene based and may act in concert to create a coordinated phased-array. Graphene (carbon nanotube fibers) wire can be used to make small coils. Graphene has a very low resistance and graphene fibers comprise a nano- structure that may allow for very small electromagnetic coils eliminating large diameter wires that result in bulky, heavy coils. The graphene based electromagnetic emitters enable unique applications especially when combined with sensors such as for example medical applications employing multi-spectral stimulation, industrial processing, biological mixing, breaking up biofilms, colloidal processing, magneto drives, and with the additional spectra also include: fusion, quantum entanglement, reverse-spin electrical production and hyper-spectral analysis.

[16] An AMTS device of the present disclosure can be used to treat neuropsychiatric conditions and enhance or otherwise improve physiological functions. Physiological functions include concentration, sleep, alertness, memory, blood pressure, stress, libido, speech, motor function, physical performance, cognitive function, intelligence, height (in children) and weight. A neuropsychiatric condition includes Autism Spectrum Disorder (ASD), Alzheimer's disease, ADHD, schizophrenia, anxiety, chronic pain, depression, coma, Parkinson's disease, substance abuse, bipolar disorders, sleep disorders, sexual dysfunction, eating disorders, tinnitus, traumatic brain injury, post-traumatic stress syndrome (PTSD), and fibromyalgia. In some embodiments, the AMTS device is suited to treat neuropsychiatric disorders that have poor coherence across different regions of the brain, such as, for example, Alzheimer's disease, speech and language disorders, schizophrenia, and depression by treating two or more regions of the brain simultaneously. Thus, in some embodiments, the AMTS can target front and rear regions of the brain, the motor cortex and frontal cortex regions of the brain, or the lateral sides of the frontal lobe region of the brain for individualized treatment.

[17] An AMTS device may comprise three components, a therapy unit (e.g. therapy unit 100 of FIG. 1 ), a cap unit (e.g. cap unit 200 of FIG. 2), and one or more nodes (e.g. nodes 236 of FIG. 2 and/or 300 of FIG. 3). Turning now to FIG. 1 illustrating a block diagram of a therapy unit according to certain aspects of the present disclosure. Therapy unit 100 directs the cap unit and nodes in the application of emitter based treatment and sensor data collection. Therapy unit 100 comprises controller 104 that controls the operation of the therapy unit. In some embodiments, the controller 104 may comprise a processor, an application specific integrated circuit (ASIC), or the like. Controller 104 may be connected to network interface 124 which may enables the therapy unit to connect to one or more external devices. For example, an AMTS device may connect via a wired or wireless connection to an external environment (e.g. a server, a cloud environment, a nearby smartphone, or the like) to distribute treatment data to relevant medical personnel (e.g. diagnostic operator, doctor, or the like).

[18] Therapy unit 100 may be operated through user interface 1 12. User interface 1 12 is a man-machine interface that enables a user (e.g. diagnostic operator, doctor, or patient) to configure and operate an AMTS device. Interface 1 12 may comprise display 1 16 (e.g. a liquid crystal display (LCD) screen) and one or more user input devices 120. In some embodiments, display 1 16 is a touchscreen display that enables a user to enter input through the display itself. A touchscreen display may replace the need for other input devices, simplifying the structure of therapy unit 100 and increasing the ease at which the device may be cleaned or sterilized. In some embodiments, user input device 120 may comprise a keyboard and/or mouse. Other types of displays and user input devices may be used without departing from the spirit or scope of the present disclosure. [19] Node engine 156 configures the nodes to deliver the preferred treatment to one or more selected regions of a patient's brain simultaneously. Node engine 156 uses real-time neuro-metrics (e.g. one or more sensors) as input into a realtime Genetic algorithm (GA), which is overseen by a hybrid combination of Artificial Intelligence (Al) and Fuzzy-Logic (FL) algorithms. The hybrid combination of algorithms can be used to deliver, in a non-limiting example, magnetic flux, radiofrequency energy, and light photons at select waveform combinations to the brain at the discretion of therapy unit 100, a diagnostic operator, a doctor, or patient.

[20] Node engine 156 and calibration engine 152 communicate with a cap unit 164 of AMTS device 164 using node interface 160. A Node interface may ensure that any therapy unit can communicate with any cap unit of an AMTS device. Node engine 156 receives sensor data (e.g. an EEG) from the nodes connected to the cap unit (e.g. nodes 236 of FIG. 2) in real-time and matches the sensor data to condition profiles 136 stored in data store 128. The condition profiles may correlate specific brainwave patterns with the regions of the brain that may cause them. Node engine 156 can use the matched condition profile to configure the specific frequency, amplitude, and duration combinations for multiple emitters that are capable of targeting the regions of a patient's brain associated with a condition profile. For example, for treating a patient with brainwave patterns that match Alzheimer's disease, node engine 156 may configure the nodes positioned over the front and rear portions of the brain. Once configured the nodes treat the one or more regions of a patient's brain simultaneously and gather a second set of sensor data to immediately measure the result of treatment. Node engine 156 moves the diagnosis/analysis/treatment/result cycle from weakly associated periodicities (e.g. weekly, monthly etc .. ) to near contemporaneous, diagnosis/analysis/treatment/result.

[21] Data store 128 additionally stores calibration profiles 132 used by calibration engine 152 to calibrate an AMTS device based on a previous calibration. For example, a patient may be fitted with an AMTS device for a previous treatment session and upon returning, the diagnostic operator, doctor, or patient may identify a stored calibration profile for the patient and load the profile. A stored calibration profile can enable calibration engine 152 to use the previous calibration results to avoid taking the time to recalibrate the device. However, if the patient does not have a previous calibration profile, then calibration engine 152 can automatically calibrate the AMTS device once the cap is placed onto the patient's head. In some embodiments, the calibration engine 152 can automatically calibrate an AMTS device regardless of the patient's head size or shape or of where the individual emitters are subsequently located on the patients head. In some embodiments, the cap of an AMTS device may be fitted onto a patient's head with respect to a fixed reference point such as the patient's ear. The nodes of the AMTS device are then disposed in a static location on the cap such that when the cap is fitted according to the reference point, the nodes are placed over the appropriate brain regions of a particular patient.

[22] Data store 132 may additional comprise user profiles 140, EEG readings 144, and historical EEG 148. User profiles 140 store the past treatment history of particular patients. Node engine 156 may load user profile 140 to analyze the previous treatment of a particular patient and devise a treatment plan that continues where the patient's previous treatment left off. User profile 140 may comprise data regarding past treatments including, but not limited to, sensor data such as EEG, oxygen saturation, and/or heart rate data, emitter configurations used during previous treatments, and known neural conditions of a particular patient. User profile 140 can include any data regarding previous treatments that may interest the diagnostic operator, doctor, or patient or aid in a patient's future treatment. EEG reading 144 can comprise current EEG readings that are collected in near real-time during treatment of a patient with an AMTS device. Historical EEG 148 stores past EEG readings taken previously in the same treatment session and in previous treatment sessions.

[23] FIG. 2 illustrates a block diagram of cap unit 200 that may be worn by a patient when treated using an AMTS device. Cap unit 200 may be connected to a therapy unit (e.g. therapy unit 100 of FIG. 1 ). The cap unit comprises a cap made from a mesh like fabric fitted with a plurality of attachable nodes. The cap may be a single size that stretches over a patients head or fitted for the individual patient's head size and shape. In some embodiments, the cap may be a helmet in which the patient is strapped into using a chin strap or the like. The cap may come in more than one size and the appropriate size may be selected for each patient's head size and shape for comfort and reliable therapeutic use of an AMTS device. In some embodiments, the nodes may be connected to the cap unit or therapy unit wirelessly and may be placed on the patient's head using an adhesive. Other forms of head gear may be used in place of a cap, helmet, or wireless node system without departing from the spirit or scope of the present disclosure.

[24] Cap unit 200 may connect to therapy unit 100 (e.g. of FIG. 1 ) using a detachable cable comprising both power and data throughput. For example, the cable may be a Universal Serial Bus (USB) Type-C cable. The detachable cable can enable a cap unit and/or therapy unit to be replaced according to individualized treatment requirements. A cap unit may connect with the therapy unit using two sets of cables, one for power and the other for data Cap unit may comprise one cable for power and the data could be transferred between a cap unit and therapy unit wirelessly. The cap unit may connect to the therapy unit using any number of cables or wireless configurations without departing from the spirit or scope of the present disclosure.

[25] Cap controller 228 may process commands from therapy unit 100 and data collected from nodes 236. Cap controller 228 communicates with nodes 236 through node interface 224 and with therapy unit 100 through interface 220. In some embodiments, cap controller 224 may not need to know the specific features or protocols used by individual nodes 236 as the node interface 224 manages information sent between the nodes and cap unit 200. Node interface 224 may enable the nodes to be interchangeable, replaceable, and upgradable. For example, a treatment center employing AMTS devices may have an extra set of nodes to configured each cap unit with the exact number and type of nodes for each patient.

[26] Cap controller 232 connects to data store 204 comprising configuration information 208, sensor data 212, and emitter data 216. Configuration information may comprise any information, including software instructions, necessary to operate the cap controller. For example, in some embodiments configuration information 212 comprises software such as firmware that enables the cap unit 200 to communicate with a therapy unit (e.g. therapy unit 100 of FIG. 1 ) through interface 220 and nodes 236 through node interface 224. This may enable Cap unit 200 to use configuration information 212 to configure a therapy unit to enable communication between the therapy unit and the cap unit. Configuration information 208 may additionally comprise instructions enabling cap controller to control the sensors and emitters in nodes 236. Sensor data 212 and emitter data 216 may comprise locally stored sensor and emitter data collected by nodes 236 prior to being passed to therapy unit 100. Emitter data 216 may additionally comprise recent emitter values such as spectra, amplitude, and/or duration combination values.

[27] Cap unit includes synchronization engine 232 that may operate to synchronize the two or more nodes to provide treatment to one or more regions of a patient's brain simultaneously. Synchronizing two or more nodes in operation improves the treatment of certain conditions. The synchronization engine 232 may orient two or more emitters to operate in a phased-array. A phased-array involves an array of emitters (i.e. two or more emitters) in which the relative phases of the signals emitted from the array create a single emission that is reinforced in a desired direction and suppressed in undesired directions. For example, two magnetic emitters on either side of a patient's head operating at specific spectra and amplitudes create a single emission that is targeted to a specific location of the patient's brain. The phased-array emitters are tunable based on modulating each emitters spectra, amplitude, and duration such that an emitter does not need to be placed over the brain region the emitter treats. Each emitter may need to be synchronized to emit at the same time as other emitters. Synchronization engine 232 syncs two or more nodes to operate at the same time thereby configuring a phased-array system of emitters.

[28] Turning now to FIG. 3 illustrating a block diagram of node such as node 236 of FIG. 2. Node 300 comprises at least one sensor 304 but may include any number of sensors. In some embodiments, sensor 304 comprises a dry non- contact Electroencephalography (EEG) sensor 308. An EEG sensor records electrical activity in the brain and is used to generate brainwave patterns that can be used to direct the emitters. Sensors 304 include, but are not limited to, EEG 308, oxygen saturation 312, heart rate 316, magnetic sensor 320, and radio frequency (RF) sensor 324. The sensors output the collected data in an analog signal, but each node may be in communication with the cap unit (e.g. cap unit 200 FIG. 200) through digital signal processing. Each sensor passes data to a bank of digitizers 328. In some embodiments, each sensor may have a corresponding digitizer that converts the analog output of the sensor into a digital signal. However, one digitizer may operate for more than one sensor without departing from the spirit or scope of the present disclosure. Each digitizer sends the digital signal to cap interface 356 which communicates the digital sensor data to the cap unit.

[29] Each node includes at least one emitter (e.g. magnetic emitter 364), but may in some embodiments comprise a magnetic, RF, laser and/or other types of emitters. In some embodiments, each node comprises at least one sensor (e.g. EEG sensor) and one type of emitter (e.g. magnetic emitter 364). Each node may be replaceable and can be quickly switched out with another node comprising a different emitter type (e.g. an RF emitter). Thus, a diagnostic operator, doctor, patient, or the like can quickly and easily switch out a magnetic emitting node for a laser emitting node without needing specialized tools, equipment, or significant time.

[30] In some embodiments, each node comprises at least one sensor and a magnetic, RF, and laser emitter. Since magnetic and RF waves interfere with each other the magnetic and RF emitters may not emit at the same time but my pulse intermittently to enable both magnetic and RF emitters to work in a series. However, the magnetic and laser or RF and laser emitters can operate simultaneously. Nodes operating in a phased-array or otherwise at the same time operate in sync using synchronization controller 380. Synchronization controller receives a time pulse from a synchronization engine (e.g. synchronization engine 232 of FIG. 2) indicating the moment in which each emitter should operate. Cap interface 356 receives the operating characteristics for each emitter (e.g. spectra, amplitude, and duration of emission) from the cap unit and passes the information to drivers 384. Each driver may correspond to a particular emitter (e.g. magnetic driver 388 corresponds to magnetic emitter 364). RF emitter 368 receives data from RF driver 392 and laser emitter 372 receives data from laser driver 396 etc... The driver may modify the data received by cap interface 356 into a format that is usable by the emitter. Generally, each emitter may process analog data. Yet, since cap interface 356 receives digital data, drivers convert the digital input into an analog output that each emitter can process. Driver may increase the strength of the data received by interface 356 to cause each emitter operate at a required intensity during treatment.

[31] A cap unit can be calibrated to identify the spatial orientation of the nodes on the patient's head as will be further clarified in connection FIG. 5 below. In some embodiments, each node comprises a sensor (e.g. magnetic sensor 320 or RF sensor 324) that may pick up a signal from another node. For example, a first node emits a magnetic pulse at a specific frequency and amplitude and another node detects the magnetic pulse some short period of time later. The time between sending and receiving the magnetic pulse as well as any deviation in spectra and amplitude can be used to identify the distance between nodes as well as any phase delay between the nodes that should be addressed. In some embodiments, each node may use magnetic emitter 364 and/or RF emitter 368 to detect the magnetic (or RF pulse) from another node.

[32] One or more blocks of therapy unit, cap unit, and nodes (e.g. units 100, 200, and 300 of FIG. 1 -3 respectively) may be embodied as one or more interconnected circuits, or as one or more software algorithms embodied on one or more storage media. For example, therapy unit and cap unit may be embodied as a system on a chip (SOC) where the blocks making up the units may be embodied as hardware on the SOC or as software embedded thereon.

[33] FIGs. 4A and 4B. illustrate an exemplary flowchart for operating an AMTS such as the AMTS device described in FIGs. 1 -3. The process begins with operation 400 of FIG. 4A where the therapy unit (e.g. therapy unit 100 of FIG. 1 ) and the cap unit (e.g. cap unit 200 of FIG. 2) are configured for use with a patient. For example, the therapy unit is directed to load a patient profile (such as patient profile 140 of FIG. 1 ) of a returning patient or define a new patient profile for a new patient. The patient profile identifies past treatment sessions and calibration settings for the cap unit and nodes.

[34] The cap unit comprises a cap made from a mesh like fabric fitted with a plurality of nodes (e.g. 15 to 32). In some embodiments, the nodes may be removably attached to the cap in different orientations and locations enabling a diagnostic operator, doctor, or patient to place and orient each node individually in a manner that is best suited for the current treatment session. In some embodiments, the nodes are attached in fixed locations and treatment is preceded by a calibration step that orients the emission directions in order to target specific regions of a patient's brain.

[35] At step 404 a diagnostic operator, doctor, or patient may fit the cap onto the patient's head with the wiring connecting the cap to the therapy unit located towards the back of the patient's head. The cap unit may be fitted as close to the patient's scalp to improve sensor reading accuracy and emitter efficiency. In some embodiments, the cap may be placed according to a fixed reference point on the patient's head such as one or both of the patient's ears. A fixed reference point may simplify the calibration as each node is oriented in an appropriate location relative to treated brain regions every time the cap unit is worn by a patient. In some embodiments, the cap may be fitted onto a patient's head without considering the specific orientation of individual nodes. The therapy unit may automatically calibrate the cap and nodes (in the calibration step 408 described more fully below) when the cap is fitted onto the patient's head.

[36] After the cap unit is fitted onto a patient, the process transfers to step 408 where the cap unit and nodes are calibrated. Generally, when the cap is placed on different patient's heads, the node's final location can vary from patient to patient. To account for the variation, the cap unit may be calibrated while on the patient's head. Calibration engine can capture variations in head size and shape to prevent loss of efficacy of the AMTS device. In some embodiments where the cap is oriented via fixed reference point, the nodes may already be located over brain regions to be treated and minimal calibration may be necessary to correct for a patient's specific head shape. In some embodiments where the cap is not fitted to a patient based on a fixed reference point, the calibration generates a spatial map that defines the exact location of each node relative to the other nodes. For returning patients, the calibration engine may first load a calibration profile corresponding to the patient to automatically calibrate the cap unit according to the previous calibration. Yet, in some embodiments, the calibration engine may run a diagnostic test to determine if the calibration profile is still accurate. For a new patient, the calibration engine defines a new calibration profile for the patient by generating and storing the spatial map.

[37] Once the cap unit is calibrated, the process moves to step 412 where one or more sensors begin gathering data. The one or more sensors preferably include an EEG sensor and may additionally include an oxygen saturation sensor, a heart rate sensor, a micro tremor sensor, or the like. The sensor's collect patient data over a predetermined period of time (e.g. ten seconds to ten minutes). Once collected the sensor data may be used to direct the treatment of the patient. For example, based on the patient's EEG readings, therapy unit may identify a corresponding condition profile. The condition profile may then indicate the course of treatment associated with the patient's EEG reading by directing the spectra, amplitude, and duration of each emitter over one or more regions of the patient's brain simultaneously. The treatment is performed on the patient at step 416. Preferably, a transcranial stimulation treatment lasts anywhere from 15 to 60 seconds. After, more sensor data may be collected. The AMTS treatment provides a cycle of collecting first sensor data, providing treatment, and collecting second sensor data. The second set of sensor data may be used to determine if treatment is complete or if another round of treatment may be effective.

[38] A decision step 420, the AMTS device determines automatically or through diagnostic operator, doctor, or patient input, to continue or terminate treatment. In some embodiments, treatment may automatically terminate when the second set of sensor data indicates the patient's brainwaves match a normal brainwave pattern. According to some embodiments, treatment may terminate when the diagnostic operator, doctor, or patient determine treatment should terminate due to reaching a desired result, patient reaching their limit, or a declining efficacy of treatment. If treatment is continued, flow returns to step 416 where another round of treatment is performed on the patient followed by collecting another round of sensor data. If at decision step 420 it is decided that treatment is terminated, then the operation ends.

[39] The sensor-treatment-sensor cycle provides far greater efficacy and response rates than simple treatment alone in, for example, Autism Spectrum Disorder (ASD) and Alzheimer's disease, new indications of prophylactically protecting or reversing Chronic Traumatic Encephalopathy (CTE) and Alzheimer's disease, and real time performance enhancement, significant mood brightening, and sensory stimulation.

[40] FIG. 4B illustrates a flowchart describing some additional steps from FIG. 4A. Magnetic, RF, and laser emitters may have negative side effects under prolonged treatment. For example, treating a patient beyond the limits of a single session may produce a range of adverse health effects from slight such as dizziness and headaches to sever such as comas. Each node attached to the cap unit may comprise additional sensors to detect advance indicia of adverse health effects. For example, a patient may exhibit micro-tremors prior to exhibiting any adverse health effects. Micro-tremors are not perceptible by the human eye, but may be detected using advanced sensors embedded in each node. In some embodiments, each node comprises a micro-tremor sensor that detect micro- tremors prior to the patient exhibiting adverse health effects associated with transcranial stimulation.

[41] At 416, the diagnostic operator, doctor, or patient operates the AMTS to deliver at treatment. After treatment, the therapy unit collects sensor data including, but not limited to, EEG data and micro-tremor data. At step 422, the therapy unit analyzes the received data and determines if the micro-tremor data indicates the presence of micro-tremors in the patient. In some embodiments, the therapy unit uses statistical modeling and the patient profile to determine if the received micro-tremor data is severe enough to warrant ceasing all treatment. In some embodiments, the therapy unit may indicate any detection of micro-tremors is sufficient to cease treatment. If the sensor data does not indicate the presence of micro-tremors or if the therapy unit finds the detected micro-tremors are within threshold levels, then the processes transfers to step 420 where the EEG reading taken at 416 is analyzed to determine if further treatment is desired or necessary.

[42] The calibration of the cap (e.g. step 408 of FIG. 4A and 4B) is further illustrated according to the flowchart of FIG. 5. Since each patient's head varies in size and shape, the nodes on the cap may not be located at the precise location on every patient. Calibration of the cap improves the precision of the emitters by enabling targeted treatment of brain regions. The calibration engine (e.g. 152 of FIG. 1 ) generates a spatial map that details the exact location and orientation of each node relative to other nodes on the cap. With the exact spatial information of the nodes, the emitters may operate, in an synchronous or asynchronous mode, to treat one or more regions of a patient's brain. Calibration may also be necessary to enable magnetic and RF emitters to operate in a phased-array according to some embodiments of the present disclosure. [43] The process begins at step 500 where a first emitter (e.g. magnetic emitter) sends a pulse at a known spectra and amplitude. At step 504 the sensors (e.g. magnetic sensor 320 of FIG. 3) present in each node are used to detect the pulse from the first emitter. Yet, in some embodiments, the emitters themselves may be used to detect emissions from other emitters. The first emitter may send a predetermined number pulses in order to determine the average received pulse to further improve the accuracy of the measurements. The received pulse may vary slightly based on different factors such as the medium in which the pulse traveled (e.g. air, bone, tissue etc .. ) and the distance of the sensor from the emitter. The received pulse may vary by time received, spectra, amplitude, and phase. The difference between the known pulse and the received pulse may be stored and used during processing step 508 to determine the exact distance the first emitter is from the received emitters. For example, the time between the pulse and when it was received can be used to determine the distance between the first emitter and the receiving sensor based on the known speed of the pulse (i.e. the speed of light). At step 512, the emitters are returned to an inoperative state.

[44] At step 516, it is determined if there are remaining emitters that have not yet been tested. While an emitter has yet to be tested, at step 516 the process shifts to step 524 where the next emitter is powered on and emits a pulse that is received by sensors present in other nodes. The process continues until each node has emitted a pulse that has been detected by other nodes. Yet, not every emitter must emit a pulse in order to determine where each emitter is relative to the other emitters. For example, one emitter that emits a pulse that is detected by two other nodes may be used to calculate the spatial relationship of all three nodes without needing to emit a pulse by the remaining two nodes. In some embodiments, a single emitter may be used to calculate the relative distance to all other nodes that are present on the cap unit. In some embodiments, only a single type of emitter from each node emits a pulse for the calibration step. For example, the calibration process may only use magnetic emitters to determine the distance measurements. In some embodiments, more than one emitter may be used to increase the accuracy of the calibration. For example the magnetic emitters and the RF emitters in each node may be operated in series. [45] Once each emitter has emitted a pulse that has been picked up by a corresponding sensor, the calibration engine generates a spatial map of the cap unit. The spatial map indicates the precise location of each node relative to the other nodes on the cap. In some embodiments, one node may be in a fixed location on the cap enabling the calibration engine to determine not only the relative locations but the exact locations of each node. The calibration engine processes all the information received by the sensors during the calibration process to account for other variations in the received pulse. Phase changes (e.g. fade) may occur when passing electro-magnetic waves over varying distances or through different media such as wire, air, or human bone. For example, a magnetic pulse received at a nearby node can measure a different phase than a node that received the magnetic pulse that passed through a patient's skull. Wire length of the node may also affect the phase of the emitted or received pulse.

[46] The detected phase change for each emitter is accounted for by the calibration engine and used to create a phase delay. The phase delay compensates for the phase difference in each emitter enabling the emitters to operate in a phased-array. The phase delay prevents distortion that may be caused by a phased-array with one or more of the emitters out of phase. The difference in phase would distort the combined pulse, affecting the precise direction, spectra, and/or amplitude of the pulse. Once the calibration engine generates the spectra map and process the sensor data the calibration process terminates.

[47] FIGs. 6A, 6B, and 6C illustrate alternative processes for providing treatment (e.g. step 412 of FIG. 4A) using an AMTS device. Turning to FIG. 6A, illustrating a multi-modal AMTS device in which each node comprises a sensor and a magnetic, RF, and laser emitter. Operation begins at 600 where sensor data (e.g. EEG sensor data such as that collected at step 412 of FIG. 4) is compared to condition profiles. The condition profile associates brainwave patterns with particular neuropsychiatric conditions. If there is a match then the condition profile is used to identify appropriate treatment profile that indicates the regions of a patient's brain that should be treated with an AMTS device. For example, a patient suffering from Autism Spectrum Disorder (ASD) may have the front and rear regions of the brain treated. After a profile is matched the process moves to 608 where processes 608-628 configure the emitters for treatment.

[48] If the patient's brainwave pattern does not match a condition in the condition profile than the diagnostic operator, doctor, or patient selects a treatment profile. In some embodiments, the treatment profile may be automatically selected based on the brainwave pattern. Sensor data can be used to create a mapping of the energy (e.g. amplitude of the received sensor data) at one or more frequencies to identify regions of incoherent or non-synchronous brain activity. The therapy unit may use sensors within nodes to map areas of low amplitude (e.g. energy) by measuring the detected brainwave patterns of the brain at interested frequencies across the brain employing well-known algorithms such as least squares, low resolution brain electromagnetic tomography, and focal optimization. Areas of low energy can also be identified by measuring the Q-factor at the one or more frequencies used to map the energy of the EEC In some embodiments, the EEG reading is converted from the time domain to the frequency domain using a Fourier Series in order to detect the amplitude of particular frequencies.

[49] After a treatment profile is determined the process moves to the configuration process that begins at step 608 where a first node is selected. At step 612, a first emitter in the first node is selected. The emitter is then configured to emit a pulse at a particular spectra, amplitude, and duration according to the treatment profile. At step 620, each emitter may be synchronized according to the spatial map and calibration engine. Since each node varies in wire length and location, the pulses of two emitters that are operated at the same time may not occur simultaneously. The synchronization engine (e.g. synchronization engine 232 of FIG. 2) and synchronization controller (synchronization controller 380 of FIG. 3) account for the difference in length and distance by using the spatial map and calibration engine. Synchronization may utilize two values: synchronization pulse and an offset. The synchronization pulse indicates to the node through the synchronization controller that it is time to emit a pulse. The offset indicates the length of time a node should wait after receiving the synchronization pulse to operate a particular emitter. The offset value is specific to each emitter while the synchronization pulse is specific to each node. [50] Once the emitter is configured and synchronized, the process shift to 624 where another emitter within the node is selected for configuration and synchronization by returning to step 612. If there are no more emitters to configure then the process moves to 628 where a different node is selected by returning to step 608. The configuration and synchronization process cycles through each emitter of each node until all emitters on all nodes are configured and synchronized. One each node has been configured and synchronized the process moves from 628 to 632 where the cap unit waits until the synchronization pulse is received from the synchronization engine of the therapy unit. Once received, the process moves to step 636 where each emitter waits according to the offset the emits a pulse according the configuration of the emitter. A treatment may last anywhere from 15 to 60 seconds.

[51] At step 640 a second sensor reading is taken. The sensor reading determines if there is an improvement in the patient's brainwave pattern or if the patient is no longer susceptible to further treatment. Based on the sensor reading, the process moves to step 644 to determine if the patient should undergo another cycle of treatment. The diagnostic operator, doctor, or patient may determine if further treatment would be necessary by comparing the second sensor reading to the condition profile and to a normal sensor reading. For example, if the second sensor reading indicates the patient's brainwave patter still matches a brainwave in the condition profile, then another cycle of treatment may be effective. Yet, if the patient's second sensor reading indicates a normal sensor reading then the senor reading may be considered acceptable and the process terminates.

[52] If a diagnostic operator, doctor, or patient performs another cycle of treatment, the second sensor reading may be used to inform the therapy unit in the reconfiguration of the emitters. In some embodiments, the configuration of each emitter is sensitive to the sensor reading to improve the efficacy of the treatment on the patient. In some embodiments, the emitters remain at a static configuration until the patient's sensor reading matches a known sensor reading. Once the diagnostic operator, doctor, or patient decides to execute another treatment cycle, the process moves to 608 to configure each emitter of each node for the next treatment. [53] An example of a cycle of treatment may begin with the therapy unit analyzing a first sensor reading to identify a dominant frequency (e.g. 9.71 Hz) based on the amplitude (i.e. energy level) of the sensor reading at various frequencies of a patient's brainwave pattern. Next, the therapy unit may use the sensor to detect the energy level of the entire brain at the dominant frequency. If the therapy unit finds that the dominant frequency is missing in some brain regions, then the therapy unit configures the magnetic, RF, and laser emitters to stimulate the affected brain regions at the frequency of 9.71 Hz. The AMTS treatments may start on a daily basis for 30 minutes in order to pull up the 9.71 Hz in those missing brain regions by providing stimulation at an harmonic of one of the biological signals.

[54] Turning now to FIG. 6B illustrating a single modality AMTS device in which each node comprises at least one sensor (e.g. an EEG sensor) and only one emitter (e.g. a magnetic, RF, or laser emitter). Each node is connected to a cap unit through a quick connect cabling system using electrical or fiber based cables (e.g. USB Type-C or Category 6A etc .. ) that allow the diagnostic operator, doctor, or patient to quickly remove nodes corresponding to one node (e.g. magnetic) and replace them with nodes corresponding with another mode (e.g. RF or laser) without requiring special expertise or equipment. In some embodiments, the cables are shielded graphene yarn and connect using Snap-On connectors. When a patient requests transcranial stimulation treatment, the diagnostic operator, doctor, or patient, may quickly configure a cap unit with the nodes corresponding to the most effective modality in minutes.

[55] At step 606, the process identifies the selected modality. The modality may be selected automatically, by a matched user profile (e.g. user profile 140 of FIG. 1 ), the treatment profile identified in step 604, or manually by a diagnostic operator, doctor, or patient. Once the modality is determine the process moves to step 608 where each node is selected. At step 610, the therapy unit determines if the selected node comprises the selected modality. If the node does not have the required emitter, then the process moves to step 61 1 where the diagnostic operator, doctor, or patient removes the current node and replaces it with a node corresponding to the selected modality. If the selected node comprises the correct emitter then the process moves instead to step 616 where the emitter is configured according to the treatment profile identified in steps 600 and 604 and further described above in connection with FIG. 6A. The configuration process moves to step 628 which loops the configuration process back to step 608 so each node may comprise requisite modality and be configured accordingly.

[56] Once each emitter is configured according to the selected modality, the process moves to step 632 where each node waits to receives a synchronization pulse. At step 636, a pulse is detected and each emitter operates according to its configuration. A second sensor (e.g. EEG) reading is performed at step 640 to determine the efficacy of treatment. The second sensor reading is used to determine the most effective course action of individual patients. If the second sensor reading determines that the patient's brainwave pattern is acceptable then the process terminates. If the second sensor reading indicates further treatment may be effective the process shifts to 648. The therapy unit, diagnostic operator, doctor, or patient may analyze the second sensor reading to improve the next course of treatment. For example, the second sensor reading may determine that some frequencies of a patient's brainwave pattern have improved while other have not. Further, the unaffected or poorly affected frequencies may be further improved by a different modality than the one modality of the previous treatment. The therapy unit, diagnostic operator, doctor, or patient may then select a new modality with an improved efficacy based on the patient's second sensor reading. Each patient has an individualized treatment plan according the sensor readings taken at the time of treatment.

[57] Turning now to FIG. 6C illustrating the operation of a phased-array AMTS device. The magnetic and/or RF emitters operate in a phased-array where two or more emitters operate together to target specific regions of a patient's brain. Emitters operating in a phased-array emits at a specific spectra, amplitude, duration, and phase relative to all other emitters operating in the phased-array. In addition, each emitter may be synchronized according to a synchronization controller (e.g. synchronization controller 380 of FIG. 3). Phased-array emitters offer improved targeting of electromagnetic pulses by forming complex geometries and emission fields that can be leveraged to induce stimulation at various positional and temporal intensities. [58] The process of FIG. 6C begins according to the process described in FIG. 6A and diverges at step 618 where, in addition to configuring the spectra, amplitude, and duration of each pulse, each calibration engine may ensure each emitter participating in the phased-array operates in the correct phase. If an emitter operates out of phase with the rest of the emitters in the phased-array, it can distort the resulting emission thereby reducing the efficacy of treatment. An emitter may operate at a different phase from other emitters due to variations in the length of wire used to connect a node to the cap unit, the distance from the node to the region of the region of the brain being treated, the medium in which the emission travels (e.g. air, hair, bone, and/or brain tissue), and surrounding objects that may cause portions of an emission to be reflected towards or away from the treatment location. The calibration engine (e.g. engine 152 of FIG. 1 ) during the calibration process (e.g. FIG. 5) additionally determines the phase delay. The phase delay may then be compensated for during a phased-array emission. In some embodiments, the phase-delay is introduced to ensure that each emitter is operating in the same phase. In some embodiments, a phase- delay is introduced to cause an emitter operating in phase to operate out of phase. For example, it may be desirable to cause a phase-delay to affect a change in direction and/or intensity (e.g. amplitude) of the combined emission. The phase-delay of each emitter may be modified in any manner to produce desirable effects on the overall emission field such as direction, coherence, and/or intensity without departing from the spirit or scope of the present disclosure.

[59] Returning to step 618, the therapy unit may first identify the emitters (e.g. between two or more) that will be participating the phased-array. The node engine (e.g. node engine 156 of FIG. 1 ) determines the appropriate phased-array attributes for each emitter. For example, a first emitter may operate on a first spectra and amplitude. In order to shape the resulting emission field, a second emitter may introduce a slightly different spectra, and amplitude to shift the emission direction and shape in the desired location. The calibration engine may then determine the phased delay of each emitter. The phased-delay may be introduced into a emitter's pulse such that when the pulse interacts with the emissions from other emitters, the combined pulse is in coherence. The process continues configuring each emitter and moves to step 632 and 636 where a synchronization pulse is detected causing each emitter operating in the phased- array to operate in synch to create the phased-array emission in the desired spectra, amplitude, and duration according to the configuration and phased-array attributes of each emitter.

[60] Once treatment terminates the process determines at step 644 to continue a subsequent cycle of treatment or to terminate. If the process continues, then the second sensor reading, taken at step 640, may be used to determine if the configuration and/or phased-array attributes of each emitter should be updated. The second sensor reading may indicate further treatment would be effective in the same, slightly different, or entirely different brain regions and cause the therapy unit to provide a new configuration and phased-array attributes accordingly. In some embodiments magnetic and/or RF sensors (e.g. sensors 320 and 324 respectively of FIG. 3) may continuously monitor each emitter during the phased-array to determine the accuracy of calibration engine. The magnetic and/or RF sensor data may be used to further refine the phased-array attributes. The treatment cycle may repeat until the therapy unit, diagnostic operator, doctor, or patient determines the second sensor reading at 640 is acceptable.

[61] The foregoing description of the embodiments, including illustrated embodiments of an AMTS device may be operated entirely manually, by a diagnostic operator, doctor, and/or patient, partially manually, or entirely automatically under the control of a therapy unit (e.g. unit 100 of FIG. 1 ). In some embodiments in which the AMTS device operates automatically, the therapy unit may direct all processes as illustrated in FIGs. 4-6 without human interaction.

[62] Implementation of the techniques, blocks, steps and means described above may be done in various ways. For example, these techniques, blocks, steps and means may be implemented in hardware, software, or a combination thereof. For a hardware implementation, the processing units may be implemented within one or more application specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), processors, controllers, micro-controllers, microprocessors, other electronic units designed to perform the functions described above, and/or a combination thereof. [63] Also, it is noted that the embodiments may be described as a process which is depicted as a flowchart, a flow diagram, a swim diagram, a data flow diagram, a structure diagram, or a block diagram. Although a depiction may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations may be re-arranged. A process is terminated when its operations are completed, but could have additional steps not included in the figure. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination corresponds to a return of the function to the calling function or the main function.

[64] Furthermore, embodiments may be implemented by hardware, software, scripting languages, firmware, middleware, microcode, hardware description languages, and/or any combination thereof. When implemented in software, firmware, middleware, scripting language, and/or microcode, the program code or code segments to perform the necessary tasks may be stored in a machine readable medium such as a storage medium. A code segment or machine- executable instruction may represent a procedure, a function, a subprogram, a program, a routine, a subroutine, a module, a software package, a script, a class, or any combination of instructions, data structures, and/or program statements. A code segment may be coupled to another code segment or a hardware circuit by passing and/or receiving information, data, arguments, parameters, and/or memory contents. Information, arguments, parameters, data, etc. may be passed, forwarded, or transmitted via any suitable means including memory sharing, message passing, token passing, network transmission, etc.

[65] For a firmware and/or software implementation, the methodologies may be implemented with modules (e.g., procedures, functions, and so on) that perform the functions described herein. Any machine-readable medium tangibly embodying instructions may be used in implementing the methodologies described herein. For example, software codes may be stored in a memory. Memory may be implemented within the processor or external to the processor. As used herein the term "memory" refers to any type of long term, short term, volatile, nonvolatile, or other storage medium and is not to be limited to any particular type of memory or number of memories, or type of media upon which memory is stored.

[66] Moreover, as disclosed herein, the term "storage medium" may represent one or more memories for storing data, including read only memory (ROM), random access memory (RAM), magnetic RAM, core memory, magnetic disk storage mediums, optical storage mediums, flash memory devices and/or other machine readable mediums for storing information. The term "machine-readable medium" includes, but is not limited to portable or fixed storage devices, optical storage devices, and/or various other storage mediums capable of storing that contain or carry instruction(s) and/or data.

[67] While the principles of the disclosure have been described above in connection with specific apparatuses and methods, it is to be clearly understood that this description is made only by way of example and not as limitation on the scope of the disclosure.

Claims

WHAT IS CLAIMED IS:

1 . An apparatus comprising:

a stimulation device comprising at least one emitter, the at least one emitter configured to stimulate one or more regions of a patient's brain simultaneously, wherein the at least one emitter is selected from the group comprising: a magnetic emitter, a radio frequency (RF) emitter, and a laser emitter;

at least one sensor configured to collect brainwave data when the at least one emitter is inoperative; and

wherein the at least emitter is replaceable with a different type of emitter.

2. An apparatus comprising:

a stimulation device comprising at least one node, the at least one node configured to stimulate one or more regions of a patient's brain simultaneously; and

wherein the at least one node comprises a magnetic emitter, a radio frequency (RF) emitter, a laser emitter, and a sensor; and

wherein the sensor is configured to collect brainwave data when the magnetic emitter and RF emitter are inoperative in order to further configure the magnetic, RF, and laser emitters.

3. A method of calibrating at least two emitters comprising:

selecting a first emitter from the at least two emitters;

sending an emission from the first emitter of the at least two emitters;

receiving, by one or more sensors, the sent emission from the first emitter; calculating the difference between the sent emission and emission received by the one or more sensors; and

generating a spatial map based on the calculated difference that indicates the relative distances between the at least two emitters.

4. An apparatus comprising:

at least one sensor disposed on a stimulation device, wherein the at least one sensor is configured to detect sub-dermal motion;

at least one emitter, the at least one emitter configured to stimulate one or more regions of a patient's brain simultaneously, wherein the at least one emitter is selected from the group comprising: a magnetic emitter, a radio frequency (RF) emitter, and a laser emitter;

a controller configured to operate the stimulation device by directing the emitter to treat one or more regions of a patient's brain while continuously receiving sensor data; and

wherein the controller ceases operation of the stimulation device based on the received sensor data.

5. A method comprising:

calibrating a stimulation device, wherein the stimulation device comprises at least one emitter and at least one sensor;

gathering first data from the at least one sensor;

operating the at least one emitter to stimulate one or more regions of a patient's brain simultaneously based on the first data;

gathering second data from the at least one sensor;

operating the at least one emitter to stimulate one or more regions of a patient's brain simultaneous based on the second data.

6. An apparatus comprising:

a stimulation device configured to stimulate one or more regions of a patient's brain simultaneously;

at least two nodes comprising at least one emitter and at least one sensor; a controller configured to generate a spatial map indicating the relative locations of the at least two nodes, wherein the spatial map defines an offset for each emitter; and

wherein a first node of the at least two nodes is configured to receive a synchronization pulse from another node, wait for a period of time equal to the offset and then operate the at least one emitter.