# US 10,945,880 B2 · Systems, devices and methods for galvanic vestibular stimulation having an envelope modulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,945,880 B2 - Document ID: US10945880B2 - Status: Granted - Kind: B2 - Application number: 15/757,140 - Filed: 2016-09-01 - Published: 2018-09-06 - Granted: 2021-03-16 - Earliest claimed: 2015-09-04 - Assignees: Scion NeuroStim, LLC - Applicants: Scion Neurostim, LLC - Inventors: Robert D. Black; Lanty L. Smith; Lesco L. Rogers - Web page: https://patentgrep.com/patent/US10945880B2 ## CPC - A61F 7/12: Devices for heating or cooling internal body cavities - A61B 6/037: {Emission tomography} - A61F 7/007: {characterised by electric heating} - 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) - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - A61N 1/0484: {Garment electrodes worn by the patient} - A61N 1/0526: {Head electrodes (A61N1/0551 takes precedence)} - A61N 1/36021: {for treatment of pain} - A61N 1/36025: {for treating a mental or cerebral condition} - A61N 1/36028: {for aversion therapy} - A61N 1/36031: {using physiological parameters for adjustment} - A61N 1/36034: {specified by the stimulation parameters} - H04R 1/1016: {Earpieces of the intra-aural type} - H04R 1/1091: {Details not provided for in groups H04R1/1008 - H04R1/1083} - A61F 2007/0005: {Ears} - A61F 2007/0075: {using a Peltier element, e.g. near the spot to be heated or cooled} - A61F 2007/0093: {programmed} - A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels} - A61M 2021/0027: {by the hearing sense} - A61M 2021/0072: {with application of electrical currents} - A61M 2021/0077: {with application of chemical or pharmacological stimulus} - A61M 2205/054: with electrotherapy - A61M 2210/0662: Ears - A61N 1/327: {for enhancing the absorption properties of tissue, e.g. by electroporation} - H04R 1/10: Earpieces; Attachments therefor {; Earphones; Monophonic headphones (H04R1/28 takes precedence; stereophonic headphones H04R5/033)} - H04R 2460/13: Hearing devices using bone conduction transducers - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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)} - 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) - H04R: LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS (producing sounds with frequency not determined by supply frequency G10K) ## Abstract A method of galvanic vestibular stimulation (GVS) may include delivering an electrical signal via transdermal electrical stimulation using a plurality of electrodes connected to a patient. The electrical signal may include an amplitude and a carrier frequency. The method may include modulating at least one of the amplitude and the carrier frequency based on a modulation waveform to modulate the electrical signal, the modulation waveform may include a modulation frequency that is less than the carrier frequency. ## Claims ### Claim 1 A method, comprising: delivering an electrical signal through galvanic vestibular stimulation (GVS) via transdermal electrical stimulation using a plurality of electrodes connected to a patient, the electrical signal comprising an amplitude and a carrier frequency; modulating at least one of the amplitude and the carrier frequency based on a modulation waveform to modulate the electrical signal delivered through GVS, the modulation waveform comprising a modulation frequency that is less than the carrier frequency; and delivering a time varying thermal waveform to the patient through caloric vestibular stimulation (CVS) simultaneous with the delivering of the modulated electrical signal through GVS, wherein the carrier frequency is at least about 3 kHz. ### Claim 2 (depends on 1) The method of claim 1, wherein the electrodes comprise earpieces that are configured to be inserted in respective ears of the patient, and wherein delivering the electrical signal comprises delivering the electrical signal via transdermal electrical stimulation through the ears of the patient. ### Claim 3 (depends on 1) The method of claim 1, wherein the modulating comprises frequency modulation of the carrier frequency of the electrical signal based on the modulation waveform. ### Claim 4 (depends on 3) The method of claim 3, wherein the frequency modulation comprises varying a frequency of electrical pulses of the electrical signal in a sinusoidal modulation. ### Claim 5 (depends on 1) The method of claim 1, wherein the modulating comprises amplitude modulation of the amplitude of the electrical signal based on the modulation waveform. ### Claim 6 (depends on 5) The method of claim 5, wherein the amplitude modulation comprises varying an amplitude of electrical pulses of the electrical signal in a sinusoidal modulation. ### Claim 7 (depends on 1) The method of claim 1, wherein the modulation frequency is between about 0.005 Hz and about 200 Hz. ### Claim 8 (depends on 1) The method of claim 1, wherein the modulation frequency is less than about 1 kHz. ### Claim 9 (depends on 1) The method of claim 1, wherein the modulation frequency is greater than about 1 kHz. ### Claim 10 (depends on 1) The method of claim 1, wherein the carrier frequency is greater than about 10 kHz. ### Claim 11 (depends on 1) The method of claim 1, further comprising: selecting the modulation frequency to induce brain rhythms in a target portion of a brain of the patient based on the modulated electrical signal. ### Claim 12 (depends on 1) The method of claim 1, further comprising: entraining endogenous brain rhythms in a target portion of a brain of the patient based on the modulated electrical signal. ### Claim 13 (depends on 1) The method of claim 1, wherein the modulating comprises modulating the modulation frequency between a lower target frequency and a higher target frequency. ### Claim 14 (depends on 13) The method of claim 13, wherein modulating the modulation frequency comprises repeatedly increasing and/or decreasing the modulation frequency in a time varying pattern between the lower target frequency and the higher target frequency. ### Claim 15 (depends on 13) The method of claim 13, wherein modulating the modulation frequency comprises repeatedly cycling the modulation frequency in a pattern of increasing from the lower target frequency to the higher target frequency and then decreasing back to the lower target frequency. ### Claim 16 (depends on 1) The method of claim 1, wherein the GVS enhances a delivery of the CVS to a target portion of a brain. ### Claim 17 (depends on 1) The method of claim 1, further comprising: acoustically delivering an audio waveform to the patient simultaneous with the delivering of the modulated electrical signal through GVS. ### Claim 18 (depends on 17) The method of claim 17, wherein the audio waveform comprises music. ### Claim 19 (depends on 17) The method of claim 17, wherein the audio waveform comprises voice. ### Claim 20 (depends on 17) The method of claim 17, wherein the modulation waveform is based on the audio waveform. ### Claim 21 (depends on 17) The method of claim 17, wherein the electrodes comprise earpieces that are configured to be inserted in respective ears of the patient, wherein the earpieces further comprise speakers that deliver the audio waveform to the patient, and wherein a perceived volume of the delivered audio waveform indicates that the earpieces are in sufficient contact with ear canals of the patient for the modulated electrical signal to be delivered to the ear canals. ### Claim 22 (depends on 1) The method of claim 1, wherein the electrical signal comprises a plurality of spaced-apart packets of electrical pulses, wherein ones of the plurality of packets comprising a plurality of electrical pulses and a separation in time between adjacent ones of the plurality of packets of electrical pulses, and wherein ones of the electrical pulses comprising a width in time, an amplitude in voltage, and a separation in time between adjacent ones of the electrical pulses within a packet, and wherein modulating the electrical signal comprises modulating at least one of a quantity of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, the width in time of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, the amplitude in voltage of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, the separation in time between adjacent ones of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, and the separation in time between adjacent ones of the plurality of packets of electrical pulses based on the modulation waveform. ### Claim 23 (depends on 1) The method of claim 1, wherein the modulation waveform comprises an audio waveform. ### Claim 24 (depends on 23) The method of claim 23, wherein the audio waveform comprises music. ### Claim 25 (depends on 23) The method of claim 23, wherein the audio waveform comprises voice. ### Claim 26 (depends on 1) The method of claim 1, further comprising: selecting the modulation waveform to reduce symptoms of a neurological disease. ### Claim 27 (depends on 1) The method of claim 1, further comprising: selecting the modulation waveform to reduce symptoms of Parkinson's disease. ### Claim 28 (depends on 1) The method of claim 1, further comprising: selecting the modulation waveform to reduce symptoms of migraine headache. ### Claim 29 A galvanic vestibular stimulation (GVS) device, comprising: first and second earpieces configured to be insertable into respective ear canals of a subject, each of the first and second earpieces comprising a respective one of first and second electrodes; first and second thermoelectric devices thermally coupled to the first and second earpieces, respectively; first and second heat sinks thermally coupled to the first and second thermoelectric devices respectively and opposite the respective one of the first and second earpieces; and a controller comprising a waveform generator that is configured to deliver a modulated electrical signal to the subject through GVS via transdermal electrical stimulation through the first and second electrodes, the modulated electrical signal comprising an amplitude and a carrier frequency, at least one of the amplitude and the carrier frequency being modulated based on a modulation waveform to modulate an electrical signal, the modulation waveform comprising a modulation frequency that is less than the carrier frequency, wherein the carrier frequency is at least about 3 kHz, wherein the controller is configured to generate a first control signal to control a first time varying thermal waveform output from the first thermoelectric device and a second control signal to control a second time varying thermal waveform output from the second thermoelectric device to provide caloric vestibular stimulation (CVS) to the subject based on the first and second control signals and via the first and second thermoelectric devices. ### Claim 30 (depends on 29) The GVS device of claim 29, wherein the controller is configured to vary the carrier frequency of the electrical signal based on the modulation waveform in a frequency modulation. ### Claim 31 (depends on 30) The GVS device of claim 30, wherein the frequency modulation comprises varying a frequency of electrical pulses of the electrical signal in a sinusoidal modulation. ### Claim 32 (depends on 29) The GVS device of claim 29, wherein the controller is configured to vary the amplitude of the electrical signal based on the modulation waveform in an amplitude modulation. ### Claim 33 (depends on 32) The GVS device of claim 32, wherein the amplitude modulation comprises varying an amplitude of electrical pulses of the electrical signal in a sinusoidal modulation. ### Claim 34 (depends on 29) The GVS device of claim 29, wherein the modulation frequency is between about 0.005 Hz and about 200 Hz. ### Claim 35 (depends on 29) The GVS device of claim 29, wherein the modulation frequency is less than about 1 kHz. ### Claim 36 (depends on 29) The GVS device of claim 29, wherein the modulation frequency is greater than about 1 kHz. ### Claim 37 (depends on 29) The GVS device of claim 29, wherein the carrier frequency is greater than about 10 kHz. ### Claim 38 (depends on 29) The GVS device of claim 29, wherein the modulated electrical signal is configured to induce brain rhythms in a target portion of a brain of the subject based on the modulation frequency. ### Claim 39 (depends on 29) The GVS device of claim 29, wherein the modulated electrical signal is configured to entrain endogenous brain rhythms in a target portion of a brain of the subject based on the modulation frequency. ### Claim 40 (depends on 29) The GVS device of claim 29, wherein the controller is configured to modulate the modulation frequency between a lower target frequency and a higher target frequency. ### Claim 41 (depends on 40) The GVS device of claim 40, wherein the controller is configured to repeatedly increase and/or decrease the modulation frequency in a pattern between the lower target frequency and the higher target frequency. ### Claim 42 (depends on 40) The GVS device of claim 40, wherein the controller is configured to repeatedly cycle the modulation frequency in a pattern of increasing from the lower target frequency to the higher target frequency and then decreasing back to the lower target frequency. ### Claim 43 (depends on 29) The GVS device of claim 29, wherein the device is configured to provide the GVS simultaneous with the CVS. ### Claim 44 (depends on 43) The GVS device of claim 43, wherein the GVS enhances a delivery of the CVS to a target portion of a brain of the subject. ### Claim 45 (depends on 29) The GVS device of claim 29, wherein the controller is configured to: measure an impedance between the first and second electrodes; and determine that the measured impedance is below a threshold, the threshold indicating that the earpieces are in sufficient contact with the ear canals of the subject for the modulated electrical signal to be delivered to the ear canals. ### Claim 46 (depends on 29) The GVS device of claim 29, wherein the first and second earpieces each comprise a thin electrically insulating coating that electrically insulates the first and second electrodes from the respective ear canals of the subject at direct current (DC). ### Claim 47 (depends on 46) The GVS device of claim 46, wherein the thin electrically insulating coating comprises an anodized finish. ### Claim 48 (depends on 29) The GVS device of claim 29, further comprising: a speaker that is configured to deliver an audio waveform to the subject simultaneous with the delivery of the modulated electrical signal through GVS. ### Claim 49 (depends on 48) The GVS device of claim 48, wherein the audio waveform comprises music. ### Claim 50 (depends on 48) The GVS device of claim 48, wherein the audio waveform comprises voice. ### Claim 51 (depends on 48) The GVS device of claim 48, wherein the modulation waveform is based on the audio waveform. ### Claim 52 (depends on 48) The GVS device of claim 48, wherein the speaker is a bone conduction speaker. ### Claim 53 (depends on 48) The GVS device of claim 48, wherein the speaker comprises first and second speakers, each of the earpieces comprising a respective one of the first and second speakers, wherein the GVS device is configured to deliver the modulated electrical signal to the subject simultaneously with the audio waveform. ### Claim 54 (depends on 53) The GVS device of claim 53, wherein a perceived volume of the delivered audio waveform indicates that the earpieces are in sufficient contact with the ear canals of the subject for the modulated electrical signal to be delivered to the ear canals. ### Claim 55 (depends on 29) The GVS device of claim 29, wherein the controller further comprises a function generator that defines the modulation waveform and provides the modulation waveform to the waveform generator. ### Claim 56 (depends on 55) The GVS device of claim 55, wherein the waveform generator comprises: a second function generator that is configured to vary the amplitude of a carrier function based on an amplitude of the modulation waveform to produce a voltage-based modulated electrical signal; and a current supply that is configured to receive the voltage-based modulated electrical signal from the second function generator and produce a clamped current output that is provided to the first and second electrodes as the modulated electrical signal. ### Claim 57 (depends on 29) The GVS device of claim 29, wherein the modulated electrical signal comprises a plurality of spaced-apart packets of electrical pulses, wherein ones of the plurality of packets comprising a plurality of electrical pulses and a separation in time between adjacent ones of the plurality of packets of electrical pulses, and wherein ones of the electrical pulses comprising a width in time, an amplitude in voltage, and a separation in time between adjacent ones of the electrical pulses within a packet, and wherein the controller is configured to modulate the electrical signal by modulating at least one of a quantity of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, the width in time of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, the amplitude in voltage of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, the separation in time between adjacent ones of the plurality of electrical pulses within ones of the plurality of packets of electrical pulses, and the separation in time between adjacent ones of the plurality of packets of electrical pulses based on the modulation waveform. ### Claim 58 (depends on 29) The GVS device of claim 29, wherein the modulation waveform comprises an audio waveform. ### Claim 59 (depends on 58) The GVS device of claim 58, wherein the audio waveform comprises music. ### Claim 60 (depends on 58) The GVS device of claim 58, wherein the audio waveform comprises voice. ### Claim 61 (depends on 29) The GVS device of claim 29, wherein the modulated electrical signal is configured to reduce symptoms of Parkinson's disease. ### Claim 62 (depends on 29) The GVS device of claim 29, wherein the modulated electrical signal is configured to reduce symptoms of a neurological disease. ### Claim 63 (depends on 29) The GVS device of claim 29, wherein the modulated electrical signal is configured to reduce symptoms of migraine headache.