Methods and apparatuses for amplitude-modulated ensemble waveforms for neurostimulation

• US 9,517,351 B2
• Filed: 05/18/2015
• Issued: 12/13/2016
• Est. Priority Date: 05/17/2014
• Status: Active Grant

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thyne Global Incorporated
• Inventors: Charlesworth, Jonathan, Pal, Sumon K.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US14/715,476
• Publication Number:
  US 20150328461A1
• Time in Patent Office: 575 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2021/0072 with application of electrical currents
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique

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

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.

2. The method of claim 1, wherein the ensemble waveform comprises more than 5 component waveforms.

3. The method of claim 1, wherein the ensemble current waveform is modulated by turning off the current.

4. The method of claim 1, further comprising applying the ensemble current waveform to a user wearing the two or more electrodes.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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%.

10. 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%.

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.

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.

13. The method of claim 12, wherein the ensemble waveform comprises more than 5 component waveforms.

14. The method of claim 12, wherein the ensemble current waveform is modulated by turning off the current.

15. The method of claim 12, further comprising applying the ensemble current waveform to a user wearing the two or more electrodes.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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%.

21. 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%.