Transdermal electrical stimulation devices for modifying or inducing cognitive state

• US 9,233,244 B2
• Filed: 03/04/2015
• Issued: 01/12/2016
• Est. Priority Date: 06/29/2013
• Status: Active Grant

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thync, Inc.
• Inventors: Pal, Sumon K., Charlesworth, Jonathan, Demers, Remi, Wetmore, Daniel Z., Goldwasser, Isy, Gradwohl, Raymond L., Lamb, Philip, Voss, Christopher, Tyler, William J.
• Primary Examiner(s): Gedeon, Brian T
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US14/639,015
• Publication Number:
  US 20150174403A1
• Time in Patent Office: 314 Days
• Field of Search: None
• US Class Current: 1/1
• 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

Abstract

Portable transdermal electrical stimulation (TES) applicators for modifying a subject'"'"'s cognitive state. In general, the portable applicators described are specifically configured and adapted to be lightweight and may be wearable, and to deliver a high-intensity TES able to evoke or enhance a predetermined cognitive effect. These TES applicators may include a pair of electrodes and a TES control module comprising a processor, a timer and a waveform generator. TES control module is adapted to deliver a biphasic electrical stimulation signal of 10 seconds or longer between the first and second electrodes having a frequency of 400 Hz or greater, a duty cycle of greater than 10 percent, an intensity of 3 mA or greater, with a DC offset.

Claims

1. A method of modifying a subject'"'"'s cognitive state, the method comprising:

activating a transdermal electrical stimulation (TES) applicator to deliver a pulsed, asymmetric, biphasic transdermal electrical stimulation having a frequency of 750 Hz or greater and an intensity of greater than 3 mA between a first electrode positioned on the subject'"'"'s skin on a temple or forehead region on a first side of the subject'"'"'s body and a second electrode on the subject'"'"'s skin on either the mastoid region of the first side of the subject'"'"'s body or on the subject'"'"'s neck; and

modifying the subject'"'"'s cognitive state by applying the biphasic transdermal electrical stimulation between the first and second electrodes for 10 seconds or longer.

2. The method of claim 1, wherein modifying the subject'"'"'s cognitive state by applying the biphasic transdermal electrical stimulation for 10 seconds or longer comprises applying intervals of the biphasic transdermal stimulation having a frequency of 750 Hz or greater and an intensity of greater than 3 mA during the 10 seconds or longer.

3. The method of claim 1, further comprising wearing the TES applicator on the subject'"'"'s head or neck.

4. The method of claim 1, wherein activating the TES applicator to deliver the pulsed, asymmetric, biphasic transdermal electrical stimulation further comprises, applying a capacitive discharge current to the electrodes to oppose any capacitance built-up during the delivery of the biphasic transdermal electrical stimulation.

5. The method of claim 1, wherein activating the TES applicator to deliver the pulsed, asymmetric, biphasic transdermal electrical stimulation further comprises, applying a capacitive discharge current periodically within each cycle of the biphasic transdermal electrical stimulation to oppose any capacitance built-up during the delivery of the biphasic transdermal electrical stimulation.

6. The method of claim 1, wherein activating the TES applicator comprises activating the TES applicator to deliver the biphasic transdermal electrical stimulation having a duty cycle of greater than 10 percent.

7. The method of claim 1, wherein modifying the subject'"'"'s cognitive state comprises enhancing attention, alertness, or mental focus, and wherein the second electrode is positioned on the subject'"'"'s skin on the mastoid region of the first side of the subject'"'"'s body.

8. The method of claim 1, wherein modifying the subject'"'"'s cognitive state comprises enhancing a calm or relaxed mental state, and wherein the second electrode is positioned on the back of the subject'"'"'s neck.

9. The method of claim 1, wherein activating the TES applicator comprises wirelessly triggering activation of the TES applicator.

10. The method of claim 1, further comprising varying the applied biphasic transdermal electrical stimulation while the biphasic transdermal stimulation is applied.

11. The method of claim 1, further comprising varying the applied biphasic transdermal electrical stimulation while keeping the biphasic transdermal electrical stimulation within a duty cycle of greater than 10 percent, the frequency of 750 Hz or greater, and the intensity of greater than 3 mA.

12. The method of claim 1, further comprising ramping the biphasic transdermal electrical stimulation during the application by modifying one or more of the intensity, frequency and duty cycle from an initial state and then restoring the one or more of the intensity, frequency and duty cycle back to the initial state.

13. A method of modifying a subject'"'"'s cognitive state, the method comprising:

positioning a first electrode on the subject'"'"'s skin on a temple or forehead region on a first side of the subject'"'"'s body;

positioning an electrode on the subject'"'"'s skin on either the mastoid region of the first side of the subject'"'"'s body or on the subject'"'"'s neck;

activating a wearable transdermal electrical stimulation (TES) applicator to deliver a pulsed, asymmetric, biphasic transdermal electrical stimulation having a frequency of 750 Hz or greater and an intensity of greater than 3 mA between the first and second electrodes; and

modifying the subject'"'"'s cognitive state by applying the biphasic transdermal electrical stimulation between the first and second electrodes for 10 seconds or longer.

14. A wearable transdermal electrical stimulation (TES) applicator device for modifying a subject'"'"'s cognitive state, the device comprising:

a body;

a first connector configured to connect to a first electrode;

a second connector configured to connect to a second electrode; and

a TES control module at least partially within the body and comprising a processor, a timer and a waveform generator, wherein the TES control module is adapted to deliver a TES waveform between electrodes connected to the first and second connectors, the TES waveform comprising a pulsed, asymmetric, biphasic electrical stimulation signal having a frequency of 750 Hz or greater, a duty cycle of greater than 10 percent, and an intensity of greater than 3 mA;

wherein the TES control module is configured to modulate a parameter of the TES waveform based on received subject input.

15. The device of claim 14, wherein the TES control module comprises a user interface configured to allow the user to adjust one or more TES waveform parameter to modify the effective intensity of the TES waveform during delivery of the TES waveform.

16. The device of claim 14, wherein the first connector comprises a snap configured to connect to an electrode assembly.

17. The device of claim 14, wherein the TES control module is configured to deliver the TES waveform for greater than 10 seconds.

18. The device of claim 14, wherein the TES control module is configured to deliver the TES waveform for 10 second or longer comprises applying intervals of the biphasic transdermal stimulation having a frequency of 750 Hz or greater and an intensity of greater than 3 mA during the 10 seconds or longer.

19. The device of claim 14, wherein the second connector comprises an elongate wire.

20. The device of claim 14, further comprising a wireless receiver coupled to the TES control module.

21. The device of claim 14, wherein the first connector is on an outer surface of the body.

22. The device of claim 14, further comprising an electrode assembly comprising the first and second electrodes.

23. The device of claim 14, further comprising a power source.

24. The device of claim 14, further comprising a high-voltage power source having a voltage of greater than 40 V.

25. The device of claim 14, further comprising a manual control on the body coupled to the TES control module.

26. The device of claim 14, further comprising a capacitive discharge circuit, wherein the TES control module is configured to trigger the capacitive discharge circuit to apply a current opposing capacitance on the electrodes during the delivery of the pulsed, asymmetric, biphasic electrical stimulation.

27. The device of claim 14, wherein the TES control module is further adapted to deliver the pulsed, asymmetric, biphasic electrical stimulation signal having the frequency of 750 Hz or greater, the duty cycle of greater than 10 percent, and the intensity of greater than 3 mA, wherein the stimulation is not charge balanced.

28. A wearable transdermal electrical stimulation (TES) applicator device for modifying a subject'"'"'s cognitive state, the device comprising:

a body;

a first connector on the body configured to connect to a first electrode;

a second connector on the body configured to connect to a second electrode; and

a TES control module at least partially within the body, the TES control module including a power source, a processor, a timer, and a waveform generator, wherein the TES control module is adapted to deliver a pulsed, asymmetric, biphasic electrical stimulation signal between electrodes connected to the first and second connectors, having a frequency of 750 Hz or greater, a duty cycle of greater than 10 percent, and an intensity of greater than 3 mA, wherein the stimulation is not charge balanced; and

a wireless receiver connected to the TES control module;

wherein the wearable TES applicator weighs less than 50 grams and is configured to modulate a parameter of the TES waveform based on received subject input.