# US 9,517,351 B2 · Methods and apparatuses for amplitude-modulated ensemble waveforms for neurostimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,517,351 B2 - Document ID: US9517351B2 - Status: Granted - Kind: B2 - Application number: 14/715,476 - Filed: 2015-05-18 - Published: 2015-11-19 - Granted: 2016-12-13 - Earliest claimed: 2014-05-17 - Assignees: Thyne Global, Inc. - Applicants: Thync Global, Inc. - Inventors: Jonathan Charlesworth; Sumon K. Pal - Web page: https://patentgrep.com/patent/US9517351B2 ## CPC - A61N 1/36034: {specified by the stimulation parameters} - A61N 1/36025: {for treating a mental or cerebral condition} - A61N 1/36082: {Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease} - A61N 1/37217: {characterised by the communication link, e.g. acoustic or tactile} - A61N 1/3727: {characterised by the modulation technique} - A61M 2021/0072: {with application of electrical currents} - A61M 2205/3584: using modem, internet or Bluetooth® - A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches - A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]} - A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)} - A61N 1/0484: {Garment electrodes worn by the patient} - A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)} - 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) - 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)} ## Abstract Methods and apparatuses for amplitude modulation of all or a portion of an ensemble waveform to modify a user's cognitive state by transdermal electrical stimulation (TES). An ensemble current waveform may include a sequence of component biphasic current waveforms in which one or more parameters (such as frequency, current amplitude, percent duty cycle, and percent charge imbalance) vary between sequential component waveforms. These ensemble waveforms may be specifically configured to evoke a particular cognitive state when applied by TES. In particular, described herein are methods for applying amplitude modulation to all or a sub-set of the component waveforms in the ensemble waveform which may dramatically enhance the efficiency and effectiveness of the TES. Also described herein are methods and apparatuses for applying amplitude modulation to all or a portion of an ensemble waveform without truncating pulses of the component waveforms forming the ensemble waveform. ## Claims ### Claim 1 A method of modulating a user's cognitive state by transdermal electrical stimulation, the method comprising: delivering an ensemble current waveform for application between two or more electrodes, wherein the ensemble current waveform comprises a series of component waveforms that are sequentially delivered, wherein the component waveforms comprise biphasic pulses and wherein each component waveform in the series is different from a component waveform immediately before it and/or immediately after it in the series by one or more of: a duration, a current amplitude, a frequency, a percent charge imbalance, and a percent duty cycle; wherein, prior to delivery, one or more of the component waveforms of the ensemble current waveform is modulated by setting the current amplitude to zero at a modulation frequency for a modulation duration that does not result in truncated pulses in the delivered waveform; wherein the modulation duration is the inverse of the modulation frequency and is a multiple of an inverse of the component waveform frequency. ### Claim 2 (depends on 1) The method of claim 1, wherein the ensemble waveform comprises more than 5 component waveforms. ### Claim 3 (depends on 1) The method of claim 1, wherein the ensemble current waveform is modulated by turning off the current. ### Claim 4 (depends on 1) The method of claim 1, further comprising applying the ensemble current waveform to a user wearing the two or more electrodes. ### Claim 5 (depends on 1) The method of claim 1, further comprising applying the ensemble current waveform to a user wearing a first electrode of the two or more electrodes on the user's temple and/or forehead region and a second electrode of the two or more electrode on the neck or mastoid region. ### Claim 6 (depends on 1) The method of claim 1, wherein delivering comprises sequentially delivering the component waveforms wherein the duration of each component waveform is between about 100 milliseconds and 600 seconds. ### Claim 7 (depends on 1) The method of claim 1, wherein delivering comprises sequentially delivering the component waveforms wherein the amplitude of each component waveform is between about 3 mA and about 25 mA. ### Claim 8 (depends on 1) The method of claim 1, wherein delivering comprises sequentially delivering the component waveforms wherein the frequency of each component waveform is between about 700 Hz and about 30 kHz. ### Claim 9 (depends on 1) The method of claim 1, wherein delivering comprises sequentially delivering the component waveforms wherein the percent charge imbalance of each component waveform is between about 10% and 100%. ### Claim 10 (depends on 1) The method of claim 1, wherein delivering comprises sequentially delivering the component waveforms wherein the percent duty cycle of each component waveform is between about 20% and 80%. ### Claim 11 A method of modulating a user's cognitive state by transdermal electrical stimulation, the method comprising: delivering an ensemble current waveform for application between two or more electrodes, wherein the ensemble current waveform comprises a series of component waveforms that are sequentially delivered, wherein the component waveforms comprise biphasic pulses and wherein each component waveform in the series is different from a component waveform immediately before it and/or immediately after it in the series by one or more of: a duration, a current amplitude, a frequency, a percent charge imbalance, and a percent duty cycle; wherein, prior to delivery, one or more of the component waveforms of the ensemble current waveform is modulated by setting the current amplitude to zero at a modulation frequency for a modulation duration, wherein the modulation duration is the inverse of the modulation frequency and is a multiple of an inverse of the component waveform frequency. ### Claim 12 A method of modulating a user's cognitive state by transdermal electrical stimulation, the method comprising: delivering an ensemble current waveform for application between two or more electrodes, wherein the ensemble current waveform comprises a series of component waveforms that are sequentially delivered, wherein the component waveforms comprise biphasic pulses and wherein each component waveform in the series is different from a component waveform immediately before it and/or immediately after it in the series by one or more of: a duration, a current amplitude, a frequency, a percent charge imbalance, and a percent duty cycle; wherein, prior to delivery, one or more of the component waveforms of the ensemble current waveform is modulated by setting the current amplitude to zero at a modulation frequency for a modulation duration that does not result in truncated pulses in the delivered waveform; wherein the modulation duration is the inverse of the modulation frequency, and comprises a bursting duty cycle divided by the modulation frequency, further wherein the modulation duration is adjusted to prevent truncation of pulses in the delivered waveform. ### Claim 13 (depends on 12) The method of claim 12, wherein the ensemble waveform comprises more than 5 component waveforms. ### Claim 14 (depends on 12) The method of claim 12, wherein the ensemble current waveform is modulated by turning off the current. ### Claim 15 (depends on 12) The method of claim 12, further comprising applying the ensemble current waveform to a user wearing the two or more electrodes. ### Claim 16 (depends on 12) The method of claim 12, further comprising applying the ensemble current waveform to a user wearing a first electrode of the two or more electrodes on the user's temple and/or forehead region and a second electrode of the two or more electrode on the neck or mastoid region. ### Claim 17 (depends on 12) The method of claim 12, wherein delivering comprises sequentially delivering the component waveforms wherein the duration of each component waveform is between about 100 milliseconds and 600 seconds. ### Claim 18 (depends on 12) The method of claim 12, wherein delivering comprises sequentially delivering the component waveforms wherein the amplitude of each component waveform is between about 3 mA and about 25 mA. ### Claim 19 (depends on 12) The method of claim 12, wherein delivering comprises sequentially delivering the component waveforms wherein the frequency of each component waveform is between about 700 Hz and about 30 kHz. ### Claim 20 (depends on 12) The method of claim 12, wherein delivering comprises sequentially delivering the component waveforms wherein the percent charge imbalance of each component waveform is between about 10% and 100%. ### Claim 21 (depends on 12) The method of claim 12, wherein delivering comprises sequentially delivering the component waveforms wherein the percent duty cycle of each component waveform is between about 20% and 80%.