Transdermal electrical stimulation methods for modifying or inducing cognitive state

• US 9,014,811 B2
• Filed: 06/30/2014
• Issued: 04/21/2015
• Est. Priority Date: 06/29/2013
• Status: Expired due to Fees

• Current Assignee: Thync Global, Inc.
• Original Assignee: Thync, Inc.
• Inventors: Pal, Sumon K., Charlesworth, Jonathan, Demers, Remi, Wetmore, Daniel Z., Goldwasser, Isy, Tyler, William J., Gradwohl, Raymond L., Lamb, Philip, Voss, Christopher
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US14/320,443
• Publication Number:
  US 20150005840A1
• Time in Patent Office: 295 Days
• Field of Search: None
• US Class Current: 607/45
• 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

Methods of modifying a subject'"'"'s cognitive state by applying transdermal electrical stimulation (TES). In particular, described herein are methods of applying TES using a pair of electrodes each positioned at a particular location on the skin of the subject'"'"'s head, or the head and neck, to evoke a predetermined cognitive state using a TES applicator. In particular, described herein are methods of enhancing attention, alertness, or mental focus or of enhancing a calm or relaxed mental state by applying high-intensity TES across electrodes positioned on the subject'"'"'s temple and either the mastoid region or on the subject'"'"'s neck. The subject may control the application directly and TES may be applied by a portable, including wearable, TES applicator.

Claims

1. A method of enhancing attention, alertness, or mental focus or of enhancing a calm or relaxed mental state, the method comprising:

placing a first electrode of a portable transdermal electrical stimulation (TES) applicator on the subject'"'"'s skin on a temple region on a first side of the subject'"'"'s body;

placing 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;

activating the TES applicator to deliver a pulsed, asymmetric, biphasic transdermal electrical stimulation having a frequency of 750 Hz or greater and an intensity of or greater than 5 mA; 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 activating the portable TES applicator comprises activating the TES applicator to deliver the biphasic transdermal electrical stimulation having a duty cycle of greater than 10 percent.

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

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

5. The method of claim 1, wherein placing the first electrode and the second electrode comprises the subject placing the first electrode and the second electrode.

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

7. The method of claim 1, wherein activating the portable TES applicator comprises triggering activation of the portable TES applicator from a handheld device.

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

9. 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 5 mA.

10. The method of claim 1, further comprising ramping the biphasic transdermal electrical stimulation during the application by decreasing one or more of the intensity, frequency, or duty cycle and then increasing one or more of the intensity, frequency, or duty cycle.

11. The method of claim 1, wherein placing the first electrode on the temple region comprises placing the first electrode lateral to the subject'"'"'s eye and above the subject'"'"'s cheekbone.

12. The method of claim 1, wherein placing the first electrode on the temple region excludes placing the electrode on the subject'"'"'s orbital region.

13. The method of claim 1, wherein the first side of the subject'"'"'s body is the right side.

14. The method of claim 1, wherein placing the first electrode comprises adhesively securing the portable TES applicator to the subject'"'"'s body.

15. The method of claim 1, wherein modifying the subject'"'"'s cognitive state comprises applying the biphasic transdermal electrical stimulation between the first and second electrodes for 5 minutes or longer.

16. The method of claim 1, wherein the placing the second electrode comprises placing the second electrode on the subject'"'"'s neck above the vertebra prominens.

17. The method of claim 1, wherein the portable TES applicator is a wearable TES applicator.

18. The method of claim 1, wherein modifying the subject'"'"'s cognitive state by applying the biphasic transdermal electrical stimulation between the first and second electrodes for 10 seconds or longer comprises one or more of:

enhancing focus and attention;

enhancing alertness;

increasing focus and/or attention;

enhancing wakefulness;

increasing subjective feeling of energy;

increasing objective physiological energy levels;

increasing motivation;

increasing physiological arousal; and

evoking a physical sensation of warmth in the subject'"'"'s chest.

19. The method of claim 1, wherein modifying the subject'"'"'s cognitive state by applying the biphasic transdermal electrical stimulation between the first and second electrodes for 10 seconds or longer comprises enhancing a calm or relaxed mental state by inducing one or more of:

a state of calm within about 5 minutes of starting a TES session;

a care-free state of mind;

a mental state free of worry;

sleep;

a perception of slowing of a passage of time;

muscular relaxation;

enhanced concentration;

inhibition of distractions;

increased cognitive clarity;

increased sensory clarity;

a dissociated state;

a mild intoxication;

a euphoric state;

a relaxed state;

enhanced enjoyment of auditory and visual experiences;

reduced physiological arousal;

increased capacity to handle emotional or other stressors;

a reduction in psychophysiological arousal associated with changes in the activity of the hypothalamic-pituitary-adrenal axis;

a reduction in biomarkers of stress, anxiety, and mental dysfunction;

anxiolysis;

a state of mental clarity;

enhanced physical performance;

resilience to stress;

a physical sensation of relaxation in the periphery; and

a perception of heart beat.

20. A method of enhancing attention, alertness, or mental focus or of enhancing a calm or relaxed mental state, the method comprising:

instructing a subject to place a first electrode of a portable transdermal electrical stimulation (TES) applicator on the subject'"'"'s skin on a temple region on a first side of the subject'"'"'s body;

instructing the subject to place a second electrode on the subject'"'"'s skin on the subject'"'"'s head or neck on the first side of the subject'"'"'s body;

instructing the subject to modify their cognitive state by activating the portable TES applicator, wherein the portable TES applicator is configured to deliver a pulsed, asymmetric, biphasic transdermal electrical stimulation between the first and second electrodes, the biphasic transdermal electric stimulation having a duty cycle of greater than 10 percent, a frequency of 750 Hz or greater, an intensity of 3 mA or greater than 5 mA, and wherein the stimulation is not charge balanced.

21. A method of enhancing attention, alertness, or mental focus, the method comprising:

placing a first electrode of a wearable transdermal electrical stimulation (TES) applicator on a subject'"'"'s skin on a temple region on a first side of the subject'"'"'s body;

placing a second electrode on the subject'"'"'s skin in the mastoid region of the first side of the subject'"'"'s body;

activating the wearable TES applicator to deliver a pulsed, asymmetric, biphasic transdermal electrical stimulation having a duty cycle of greater than 10 percent, a frequency of 750 Hz or greater, and an intensity of greater than 5 mA; and

enhancing attention, alertness or mental focus by applying the biphasic transdermal electrical stimulation between the first and second electrodes for 10 seconds or longer.

22. The method of claim 21, wherein placing the first electrode and the second electrode comprises the subject placing the first electrode and the second electrode.

23. The method of claim 21, wherein activating the wearable TES applicator comprises wirelessly triggering activation of the wearable TES applicator.

24. The method of claim 21, further comprising varying the applied biphasic transdermal electrical stimulation while keeping the biphasic transdermal electrical stimulation within the duty cycle of greater than 10 percent, the frequency of 750 Hz or greater, and the intensity of greater than 5 mA.

25. The method of claim 21, further comprising ramping the biphasic transdermal electrical stimulation during the application by decreasing one or more of the intensity, frequency, or duty cycle and then increasing one or more of the intensity, frequency, or duty cycle.

26. A method of enhancing a calm or relaxed mental state, the method comprising:

placing a first electrode of a wearable transdermal electrical stimulation (TES) applicator on a subject'"'"'s skin on a temple region on a first side of the subject'"'"'s body;

placing a second electrode on the back of the subject'"'"'s neck above the vertebra prominens;

activating the wearable TES applicator to deliver a pulsed, asymmetric, biphasic transdermal electrical stimulation having a duty cycle of greater than 10 percent, a frequency of 750 Hz or greater, and an intensity of greater than 5 mA; and

enhancing a calm or relaxed mental state by applying the biphasic transdermal electrical stimulation between the first and second electrodes for 10 seconds or longer.

27. The method of claim 26, wherein placing the first electrode and the second electrode comprises the subject placing the first electrode and the second electrode.

28. The method of claim 26, wherein activating the wearable TES applicator comprises wirelessly triggering activation of the wearable TES applicator.

29. The method of claim 26, further comprising varying the applied biphasic transdermal electrical stimulation while keeping the biphasic transdermal electrical stimulation within the duty cycle of greater than 10 percent, the frequency of 750 Hz or greater, and the intensity of greater than 5 mA.

30. The method of claim 26, further comprising ramping the biphasic transdermal electrical stimulation during the application by decreasing one or more of the intensity, frequency, or duty cycle and then increasing one or more of the intensity, frequency, or duty cycle.