Methods and devices for treating primary headache

• US 9,020,598 B2
• Filed: 09/16/2013
• Issued: 04/28/2015
• Est. Priority Date: 11/10/2005
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US14/028,200
• Publication Number:
  US 20140107397A1
• Time in Patent Office: 589 Days
• Field of Search: 607 1- 2, 607/46, 607 62- 63, 607/115, 607/139, 607/142, 607/149
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Non-invasive electrical nerve stimulation devices and magnetic stimulation devices are disclosed, along with methods of treating medical disorders using energy that is delivered noninvasively by such devices. The disorders comprise migraine and other primary headaches such as cluster headaches, including sinus symptoms that resemble an immune-mediated response (“sinus” headaches), irrespective of whether those symptoms arise from an allergy that is co-morbid with the headache. The disclosed methods may also be used to treat other disorders that may be co-morbid with migraine headaches, such as anxiety disorders. In preferred embodiments of the disclosed methods, one or both of the patient'"'"'s vagus nerves are stimulated non-invasively. In other embodiments, parts of the sympathetic nervous system and/or the adrenal glands are stimulated.

Claims

1. A method of treating a headache in a patient, the method comprising:

positioning a device adjacent to a skin surface of a neck of the patient;

generating one or more electrical impulses with the device; and

transmitting, via the device, the electrical impulses to a vagus nerve of the patient, wherein the electrical impulses are sufficient to generate action potentials within fibers of the vagus nerve responsible for activating neural pathways causing a release of GABA within a brain of the patient to at least partially relieve a pain associated with the headache.

2. The method of claim 1, wherein a sufficient level of GABA is released in the brain of the patient to reduce a level of glutamate in the brain.

3. The method of claim 1, wherein the electrical impulses are sufficient to at least partially relieve said pain within about 5 minutes of the transmitting.

4. The method of claim 1, wherein the electrical impulses are generated exterior to the patient and transmitted transcutaneously through an outer skin surface of the patient to generate an electrical impulse at or near the fibers of the vagus nerve.

5. The method of claim 1, further comprising:

generating an electric field at or near the device; and

shaping the electric field such that the electric field is sufficient to modulate the vagus nerve; and

wherein the electric field is not sufficient to substantially modulate a nerve or a muscle between the skin surface and a target region within the patient.

6. The method of claim 1, wherein the transmitting is carried out by generating a magnetic field exterior to the patient, wherein the magnetic field is sufficient to induce an electrical impulse at or near the vagus nerve within the patient.

7. The method of claim 1 wherein the electrical impulses have a frequency of about 1000 Hz to about 10,000 Hz and a duty cycle of about 1% to about 10%.

8. The method of claim 7 wherein the frequency is about 4000 Hz to about 6000 Hz.

9. The method of claim 7 wherein the frequency is about 5000 Hz.

10. The method of claim 7 wherein the duty cycle is about 2% to about 5%.

11. The method of claim 7 wherein the duty cycle is about 2.5%.

12. The method of claim 7 wherein the electrical impulses comprise bursts of pulses having a burst duration of about 0.1 to about 10 milliseconds and a burst frequency of about 5 Hz to about 100 Hz.

13. The method of claim 12 wherein the burst duration is about 2 to about 6 milliseconds.

14. The method of claim 12 wherein the burst frequency is about 10 Hz to about 35 Hz.

15. The method of claim 1, wherein the electrical impulses are sufficient to cause dopaminergic neurons originating in a ventral tegmental area of the brain to stimulate neurons or tissue to which said dopaminergic neurons project.

16. The method of claim 1, wherein the electrical impulses are sufficient to modulate serotonergic neurons in a raphe nucleus within the patient.

17. The method of claim 1 wherein the headache is a migraine headache.

18. The method of claim 1 wherein the headache is a cluster headache.

19. The method of claim 1 wherein the headache is a tension headache.

20. The method of claim 1 wherein the headache is a sinus headache.

21. A method of treating a headache in a patient, the method comprising:

positioning a device adjacent to a skin surface of a neck of the patient;

generating one or more electrical impulses with the device; and

transmitting, via the device, the electrical impulses to a vagus nerve of the patient, wherein the electrical impulses are sufficient to generate action potentials within fibers of the vagus nerve responsible for activating neural pathways causing a release of a sufficient level of inhibitory neurotransmitters within a brain of the patient to reduce a level of glutamate in the brain and at least partially relieve a pain associated with the headache.

22. The method of claim 21, wherein the inhibitory neurotransmitters comprise GABA.

23. The method of claim 21, wherein the inhibitory neurotransmitters comprise serotonin.

24. The method of claim 21, wherein the inhibitory neurotransmitters comprise norepinephrine.

25. The method of claim 21, wherein the electrical impulses are sufficient to at least partially relieve said pain within 5 minutes of the transmitting.

26. The method of claim 21, wherein the electrical impulses are generated exterior to the patient and transmitted transcutaneously through an outer skin surface of the patient to generate an electrical impulse at or near the fibers of the vagus nerve.

27. The method of claim 21, further comprising:

generating an electric field at or near the device; and

shaping the electric field such that the electrical field is sufficient to modulate the vagus nerve, wherein the electric field is not sufficient to substantially modulate a nerve or a muscle between the skin surface and a target region within the patient.

28. The method of claim 21, wherein the transmitting is carried out by generating a magnetic field exterior to the patient, wherein the magnetic field is sufficient to induce an electrical impulse at or near the vagus nerve within the patient.

29. The method of claim 21, wherein the electrical impulses have a frequency from about 1,000 Hz to about 10,000 Hz and a duty cycle from about 1% to about 10%.

30. The method of claim 29, wherein the frequency is from about 4,000 Hz to about 6,000 Hz.

31. The method of claim 29, wherein the frequency is about 5,000 Hz.

32. The method of claim 29, wherein the duty cycle is from about 2% to about 5%.

33. The method of claim 29, wherein the duty cycle is 2.5%.

34. The method of claim 21, wherein the electrical impulses comprise bursts of pulses having a burst duration from about 0.1 milliseconds to about 10 milliseconds and a burst frequency from about 5 Hz to about 100 Hz.

35. The method of claim 34, wherein the burst duration is from about 2 milliseconds to about 6 milliseconds.

36. The method of claim 34, wherein the burst frequency is from about 10 Hz to about 35 Hz.

37. The method of claim 21, wherein the headache is a migraine headache.

38. The method of claim 21, wherein the headache is a cluster headache.

39. The method of claim 21, wherein the headache is a tension headache.

40. The method of claim 21, wherein the headache is a sinus headache.

41. A method of treating a headache in a patient, the method comprising:

positioning a device adjacent to a skin surface of a neck of the patient;

generating one or more electrical impulses with the device; and

transmitting, via the device, the electrical impulses to a vagus nerve of the patient, wherein the electrical impulses are sufficient to generate action potentials within fibers of the vagus nerve responsible for activating neural pathways causing a release of inhibitory neurotransmitters within a brain of the patient to at least partially relieve a pain associated with the headache, wherein the electrical impulses are sufficient to cause dopaminergic neurons originating in a ventral tegmental area of the brain to stimulate neurons or tissue to which said dopaminergic neurons project.

42. The method of claim 41, wherein the inhibitory neurotransmitters comprise serotonin.

43. The method of claim 41, wherein the inhibitory neurotransmitters comprise norepinephrine.