# US 10,946,165 B2 · Modulation of brainwave activity using non-invasive stimulation of sensory pathways > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,946,165 B2 - Document ID: US10946165B2 - Status: Granted - Kind: B2 - Application number: 15/571,583 - Filed: 2016-05-04 - Published: 2018-08-09 - Granted: 2021-03-16 - Earliest claimed: 2015-05-04 - Assignees: Phoenix NeuroStim Therapeutics, LLC - Applicants: Phoenix NeuroStim Therapeutics, LLC - Inventors: Steven Metzger - Web page: https://patentgrep.com/patent/US10946165B2 ## CPC - A61M 21/02: for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia (for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021) - A61B 5/168: {Evaluating attention deficit, hyperactivity} - A61B 5/291: for electroencephalography [EEG] - A61B 5/378: Visual stimuli - A61B 5/38: Acoustic or auditory stimuli - A61B 5/4064: {Evaluating the brain (for intracranial pressure A61B5/031; for cerebral blood gases A61B5/14553; using EEG A61B5/369)} - A61B 5/6803: {Head-worn items, e.g. helmets, masks, headphones or goggles} - A61B 5/6814: {Head} - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - A61N 1/0484: {Garment electrodes worn by the patient} - A61N 1/36025: {for treating a mental or cerebral condition} - A61B 2562/0209: Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053 - A61M 2021/0022: {by the tactile sense, e.g. vibrations} - A61M 2021/0027: {by the hearing sense} - A61M 2021/005: {images, e.g. video} - A61M 2021/0072: {with application of electrical currents} - A61M 2230/10: Electroencephalographic signals - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract Methods and apparatus for modulation of the central nervous system, and more particularly for modulation of brain oscillatory activity and the brain networks that give rise to it. The methods involve using one or more non-invasive stimuli, either alone or in combination, to increase, decrease, or otherwise modulate neural oscillations in the brain. Also described are methods and devices for detecting sub-optimal or pathological neural oscillatory patterns, developing treatment protocols to modify the neural oscillations in a desired manner, introducing a non-invasive stimulus or stimuli through one or more sensory pathways to treat the conditions, and adjusting the treatment protocol to improve the therapeutic effect of the stimulus or stimuli. ## Claims ### Claim 1 A wearable neuromodulation device, comprising: at least one stimulator configured to output a bandwidth-limited sensory stimulus to a sensory organ of a user of the wearable neuromodulation device in accordance with stimulation parameters included in a neuromodulation protocol, wherein the bandwidth-limited sensory stimulus is configured to stimulate sensory neurons in the sensory organ, the sensory organ forming part of a sensory pathway, the sensory pathway being an auditory pathway, a visual pathway or a somatosensory pathway, the sensory pathway being connected to one or more brain regions in one or more brain networks of the user, thereby modulating neural activity within a brainwave frequency band or bands; and controller circuitry configured to: transmit the stimulation parameters to the at least one stimulator in accordance with the neuromodulation protocol to provide neuromodulation of the one or more brain regions in the one or more brain networks; receive input data representing performance of a task by the user of the wearable neuromodulation device following stimulation of the sensory organ with the bandwidth-limited sensory stimulus; and adjust, during operation of the wearable neuromodulation device, the stimulation parameters transmitted to the at least one stimulator based, at least in part, on the received input data. ### Claim 2 (depends on 1) The wearable neuromodulation device of claim 1, further comprising: at least one sensor configured to sense an effect of the neuromodulation, wherein adjusting the stimulation parameters transmitted to the at least one stimulator is further based, at least in part, on the effect of the neuromodulation sensed by the at least one sensor. ### Claim 3 (depends on 2) The wearable neuromodulation device of claim 2, wherein the at least one sensor is configured to sense the effect of the neuromodulation during operation of the wearable neuromodulation device. ### Claim 4 (depends on 2) The wearable neuromodulation device of claim 2, wherein the controller circuitry is further configured to compare the effect of the neuromodulation sensed by the at least one sensor to at least one target value, and wherein adjusting the stimulation parameters comprises adjusting the stimulation parameters based, at least in part, on the comparison of the effect of the neuromodulation sensed by the at least one sensor and the at least one target value. ### Claim 5 (depends on 2) The wearable neuromodulation device of claim 2, wherein the controller circuitry is further configured to: determine, based on the neuromodulation protocol, sensor information; and transmit the sensor information to the at least one sensor to initialize and/or configure the at least one sensor prior to stimulation with the wearable neuromodulation device. ### Claim 6 (depends on 5) The wearable neuromodulation device of claim 5, wherein initializing the at least one sensor comprises recording a baseline sensor measurement and providing the baseline sensor measurement to the controller circuitry, wherein the controller circuitry is further configured to adjust the stimulation parameters specified in the neuromodulation protocol based, at least in part, on the baseline sensor measurement. ### Claim 7 (depends on 1) The wearable neuromodulation device of claim 1, wherein the at least one stimulator includes a first stimulator configured to output a first bandwidth-limited sensory stimulus and a second stimulator configured to output a second bandwidth-limited sensory stimulus having at least one characteristic different from the first bandwidth-limited sensory stimulus. ### Claim 8 (depends on 7) The wearable neuromodulation device of claim 7, wherein the first bandwidth-limited sensory stimulus is configured to be output to a first sensory organ, and the second bandwidth-limited sensory stimulus is configured to be output to a second sensory organ. ### Claim 9 (depends on 7) The wearable neuromodulation device of claim 7, wherein each of the first bandwidth-limited sensory stimulus and the second bandwidth-limited sensory stimulus is a stochastic stimulus. ### Claim 10 (depends on 1) The wearable neuromodulation device of claim 1, wherein the neuromodulation protocol identifies the one or more brain regions to be modulated, one or more brainwave frequency bands within the one or more brain regions to be modulated, a desired outcome of the modulation, and one or more conditions under which the modulation is to take place. ### Claim 11 (depends on 1) The wearable neuromodulation device of claim 1, wherein the bandwidth-limited sensory stimulus is configured to inhibit and/or desynchronize neural oscillations in at least one of the one or more of the brain regions in the one or more networks. ### Claim 12 (depends on 1) The wearable neuromodulation device of claim 1, wherein adjusting the stimulus parameters comprises modifying the bandwidth-limited sensory stimulus to modulate a particular brainwave frequency band or bands within which neural activity is modulated. ### Claim 13 (depends on 1) The wearable neuromodulation device of claim 1, wherein the stimulation parameters include timing parameters for the bandwidth-limited sensory stimulus. ### Claim 14 (depends on 13) The wearable neuromodulation device of claim 13, wherein the timing parameters indicate whether the bandwidth-limited sensory stimulus is to be presented continuously, intermittently, or in response to the occurrence of a condition. ### Claim 15 (depends on 1) The wearable neuromodulation device of claim 1, wherein the neuromodulation protocol is selected based, at least in part, on health information about the user, wherein the health information relates to a disorder associated with the user, wherein the disorder is selected from the group consisting of a thought process disorder, a memory disorder, a mental disorder, an age-related disorder, a cognitive disorder, a motor disorder, and a sensory disorder. ### Claim 16 (depends on 1) The wearable neuromodulation device of claim 1, wherein the controller circuitry is further configured to initiate transmission of the stimulation parameters to the at least one stimulator or adjust the stimulation parameters in response to input from the user of the wearable neuromodulation device. ### Claim 17 (depends on 1) The wearable neuromodulation device of claim 1, wherein the controller circuitry is further configured to initiate transmission of the stimulation parameters to the at least one stimulator or adjust the stimulation parameters in response to contextual information about the environment of the user. ### Claim 18 (depends on 1) The wearable neuromodulation device of claim 1, wherein the at least one stimulator comprises an auditory stimulator configured to output the bandwidth-limited sensory stimulus to an auditory sensory organ. ### Claim 19 (depends on 18) The wearable neuromodulation device of claim 18, wherein the at least one stimulator further comprises a visual stimulator, and wherein the auditory stimulator and the visual stimulator are integrated on a single wearable neuromodulation device. ### Claim 20 (depends on 1) The wearable neuromodulation device of claim 1, wherein the task is performed by the user during stimulation of the sensory organ with the bandwidth-limited sensory stimulus. ### Claim 21 A method of providing neuromodulation using a wearable neuromodulation device, the method comprising: receiving a neuromodulation protocol including stimulation parameters; transmitting the stimulation parameters to at least one stimulator in accordance with the neuromodulation protocol; outputting, by the at least one stimulator, a bandwidth-limited sensory stimulus to a sensory organ of a user of the wearable neuromodulation device in accordance with the stimulation parameters to provide neuromodulation of one or more brain regions in one or more brain networks, wherein the bandwidth-limited sensory stimulus is configured to stimulate sensory neurons in the sensory organ, the sensory organ forming part of a sensory pathway, the sensory pathway being an auditory pathway, a visual pathway or a somatosensory pathway, the sensory pathway being connected to the one or more brain regions in the one or more brain networks of the user, thereby modulating neural activity within a brainwave frequency band or bands; receive input data representing performance of a task by the user of the wearable neuromodulation device following stimulation of the sensory organ with the bandwidth-limited sensory stimulus; and adjusting, during operation of the wearable neuromodulation device, the stimulation parameters transmitted to the at least one stimulator based, at least in part, on the received input data. ### Claim 22 (depends on 21) The method of claim 21, further comprising sensing an effect of the neuromodulation using at least one sensor, and wherein adjusting the stimulation parameters transmitted to the at least one stimulator is further based, at least in part, on the effect of the neuromodulation sensed by the at least one sensor. ### Claim 23 (depends on 22) The method of claim 22, wherein sensing the effect of the neuromodulation comprises sensing the effect of the neuromodulation during operation of the wearable neuromodulation device. ### Claim 24 (depends on 22) The method of claim 22, further comprising comparing the effect of neuromodulation sensed by the at least one sensor to at least one target value, and wherein adjusting the stimulation parameters comprises adjusting the stimulation parameters based, at least in part, on the comparison of the effect of neuromodulation sensed by the at least one sensor and the at least one target value. ### Claim 25 (depends on 22) The method of claim 22, further comprising transmitting sensor information indicated in the neuromodulation protocol to the at least one sensor to initialize and/or configure the at least one sensor prior to operation of the wearable neuromodulation device. ### Claim 26 (depends on 25) The method of claim 25, wherein initializing the at least one sensor comprises recording a baseline sensor measurement, and wherein adjusting the stimulation parameters comprises adjusting the stimulation parameters based, at least in part, on the baseline sensor measurement. ### Claim 27 (depends on 21) The method of claim 21, wherein the at least one stimulator includes a first stimulator configured to output a first bandwidth-limited sensory stimulus and a second stimulator configured to output a second bandwidth-limited sensory stimulus having at least one characteristic different from the first bandwidth-limited sensory stimulus. ### Claim 28 (depends on 27) The method of claim 27, wherein the first bandwidth-limited sensory stimulus is configured to be output to a first sensory organ and the second bandwidth-limited sensory stimulus is configured to be output to a second sensory organ. ### Claim 29 (depends on 27) The method of claim 27, wherein each of the first bandwidth-limited sensory stimulus and the second bandwidth-limited sensory stimulus is a stochastic stimulus. ### Claim 30 (depends on 21) The method of claim 21, wherein the neuromodulation protocol identifies the one or more brain regions to be modulated, one or more brainwave frequency bands within the one or more brain regions to be modulated, a desired outcome of the modulation, and one or more conditions under which the modulation is to take place. ### Claim 31 (depends on 21) The method of claim 21, wherein the bandwidth-limited sensory stimulus is configured to inhibit and/or desynchronize neural oscillations in at least one of the one or more brain regions in the one or more networks. ### Claim 32 (depends on 21) The method of claim 21, wherein adjusting the stimulus parameters comprises modifying the bandwidth-limited sensory stimulus to modulate a particular brainwave frequency band or bands within which neural activity is modulated. ### Claim 33 (depends on 21) The method of claim 21, wherein the stimulation parameters include timing parameters for the bandwidth-limited sensory stimulus. ### Claim 34 (depends on 33) The method of claim 33, wherein the timing parameters indicate whether the bandwidth-limited sensory stimulus is to be presented continuously, intermittently, or in response to the occurrence of a condition. ### Claim 35 (depends on 21) The method of claim 21, further comprising selecting the neuromodulation protocol based, at least in part, on health information about the user, wherein the health information relates to a disorder associated with the user, wherein the disorder is selected from the group consisting of a thought process disorder, a memory disorder, a mental disorder, an age-related disorder, a cognitive disorder, a motor disorder, and a sensory disorder. ### Claim 36 (depends on 21) The method of claim 21, further comprising initiating transmission of the stimulation parameters to the at least one stimulator or adjusting the stimulation parameters in response to input from the user of the wearable neuromodulation device. ### Claim 37 (depends on 21) The method of claim 21, further comprising initiating transmission of the stimulation parameters to the at least one stimulator or adjusting the stimulation parameters in response to contextual information about the environment of the user. ### Claim 38 (depends on 21) The method of claim 21, wherein the task is performed by the user during stimulation of the sensory organ with the bandwidth-limited sensory stimulus. ### Claim 39 A wearable integrated neuromodulation device comprising: at least one stimulator configured to output a bandwidth-limited sensory stimulus to a sensory organ of a user of the wearable integrated neuromodulation device in accordance with stimulation parameters, wherein the bandwidth-limited sensory stimulus is configured to stimulate sensory neurons in the sensory organ, the sensory organ forming part of a sensory pathway, the sensory pathway being an auditory pathway, a visual pathway or a somatosensory pathway, the sensory pathway being connected to one or more brain regions in one or more brain networks of the user, thereby modulating neural activity within a brainwave frequency band or bands; at least one power source configured to provide operating power to at least one of the at least one stimulator and at least one sensor; and controller circuitry configured to: transmit the stimulation parameters to the at least one stimulator in accordance with the neuromodulation protocol to provide neuromodulation of the one or more brain regions in the one or more brain networks; receive input data representing performance of a task by the user of the wearable neuromodulation device following stimulation of the sensory organ with the bandwidth-limited sensory stimulus; and adjust, during operation of the wearable integrated neuromodulation device, the stimulation parameters transmitted to the at least one stimulator based, at least in part, on the received input data.