NON-INVASIVE MAGNETIC OR ELECTRICAL NERVE STIMULATION TO TREAT OR PREVENT DEMENTIA

• US 20130066392A1
• Filed: 11/08/2012
• Published: 03/14/2013
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Granted Patent: US 10,232,178 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4088 Diagnosing of monitoring cognitive diseases, e.g. Alzheimer, prion diseases or dementia
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes 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 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• 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 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Devices, systems and methods are disclosed for treating or preventing dementia, such as Alzheimer'"'"'s disease. The methods comprise transmitting impulses of energy non-invasively to selected nerve fibers, particularly those in a vagus nerve, that modulate the activity of a patient'"'"'s locus ceruleus. The transmitted energy impulses, comprising magnetic and/or electrical energy, stimulate the selected nerve fibers to cause the locus ceruleus to release norepinephrine into regions of the brain that contain beta-amyloids. The norepinephrine counteracts neuroinflammation that would damage neurons in those regions and the locus ceruleus, thereby arresting or slowing the progression of the disease in the patient.

Claims

1. A method of treating or preventing dementia in a patient, comprising:

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

generating one or more electrical impulses with said device; and

transmitting the electrical impulses to selected nerve fibers in the patient, wherein the electrical impulses are sufficient to modify dementia within the patient.

2. The method of claim 1 wherein the transmitting step comprises transmitting the electrical impulses from one or more electrodes through a conducting medium within the device.

3. The method of claim 1 wherein the electrical impulses are transmitted transcutaneously through an outer skin surface of the patient to generate an electrical impulse at or near the selected nerve fibers.

4. The method of claim 3 further comprising generating an electrical field at or near the device and shaping the electrical field such that the electrical field is sufficient to modulate a nerve fiber at the target region;

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

5. The method of claim 4 wherein the electric field at the nerve fiber at the target region is between about 10 to 600 V/m.

6. The method of claim 5 wherein the electric field is less than 100 V/m.

7. The method of claim 4 wherein the nerve fiber at the target region is at least approximately 0.5-2 cm below an outer skin-surface of the patient.

8. The method of claim 1 wherein the selected nerve fibers are associated with a vagus nerve of the patient.

9. The method of claim 1 wherein the electrical impulses comprise bursts of pulses with a frequency of between about 1 to 100 bursts per second.

10. The method of claim 9 wherein each bursts contains between 1 and 20 pulses.

11. The method of claim 9 wherein the pulses are full sinusoidal waves.

12. The method of claim 9 wherein each pulse is about 100 to 1000 microseconds in duration.

13. The method of claim 12 wherein the duration of a pulse within a burst is about 200 microseconds, wherein the number of pulses per burst is between 4 and 6, and wherein the number of bursts per second is between 20 and 30.

14. The method of claim 1 wherein the selected nerve fibers control or modulate the release of catecholamines.

15. The method of claim 1 wherein the selected nerve fibers are afferent nerve fibers.

16. The method of claim 1 the electrical impulses generate an electric field at the vagus nerve above a threshold for generating action potentials within A and B fibers of the vagus nerve and below a threshold for generating action potentials within C fibers of the vagus nerve.

17. The method of claim 1 wherein the electrical impulses generate an electric field at the vagus nerve above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating neural pathways causing release of inhibitory neurotransmitters within a brain of the patient.

18. The method of claim 17 wherein the inhibitory neurotransmitters comprise norepinephrine.

19. The method of claim 18 wherein the norepinephrine is released into a resting state neural network of the patient.

20. The method of claim 18 wherein the norepinephrine counteracts neuroinflammation in or around the locus ceruleus.

21. The method of claim 19 wherein the resting state network is a default mode network or a ventral attention network.

22. A device for treating or preventing dementia in a patient comprising:

a housing having an electrically permeable contact surface for contacting an outer skin surface of the patient;

an energy source within the housing configured to generate an electric field sufficient to transmit an electric current through the outer skin surface of the patient to a nerve at a target region within the patient;

wherein the electric current is sufficient to treat dementia in the patient.

23. The device of claim 22 wherein the energy source comprises a signal generator and one or more electrodes coupled to the signal generator within the housing.

24. The device of claim 23 further comprising a conducting medium within the housing between the electrodes and the electrically permeable contact surface.

25. The device of claim 22 wherein the energy source comprises a battery.

26. The device of claim 22 wherein the electric field comprises bursts of pulses with a frequency of about 1 to about 100 bursts per second.

27. The device of claim 26 wherein the electric field comprises bursts of between 1 and 50 pulses per burst, with each pulse being about 50 to 1000 microseconds in duration.

28. The device of claim 22 wherein the electric current is sufficient to stimulate a vagus nerve of the patient.

29. The device of claim 22 wherein the housing is a handheld device configured for contacting a surface of the skin of a patient.

30. The device of claim 22 wherein the electrical impulses generate an electric field at the vagus nerve above a threshold for generating action potentials within A and B fibers of the vagus nerve and below a threshold for generating action potentials within C fibers of the vagus nerve.

31. The method of claim-22 wherein the electrical impulses generate an electric field at the vagus nerve above a threshold for generating action potentials within fibers of the vagus nerve responsible for activating neural pathways causing release of inhibitory neurotransmitters within a brain of the patient.

32. The method of claim 31 wherein the inhibitory neurotransmitters comprise norepinephrine.

33. The method of claim 32 wherein the norepinephrine is released into a resting state neural network of the patient.

34. The method of claim 33 wherein the norepinephrine counteracts neuroinflammation in or around the locus ceruleus.

35. The method of claim 33 wherein the resting state network is a default mode network or a ventral attention network.