Non invasive neuromodulation device for enabling recovery of motor, sensory, autonomic, sexual, vasomotor and cognitive function

• US 9,393,409 B2
• Filed: 11/13/2012
• Issued: 07/19/2016
• Est. Priority Date: 11/11/2011
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: NeuroEnabling Technologies, Inc.
• Inventors: Edgerton, Victor Reggie, Gerasimenko, Yuri P., Terrafranca, Nicholas A., Lu, Daniel C.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/357,481
• Publication Number:
  US 20140316484A1
• Time in Patent Office: 1,344 Days
• Field of Search: 607 45- 46
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

In one example embodiment, a neuromodulation system for inducing locomotor activity in a mammal, in cooperation with a signal generator and an electrode, delivers a signal with an overlapping high frequency pulse to a mammal.

Claims

1. A neuromodulation system for inducing locomotor activity in a mammal, the neuromodulation system comprising:

a processor;

a first signal generator;

a second signal generator;

an electrode; and

a memory device storing instructions which when executed by the processor, causes the processor, in cooperation with the first signal generator, the second signal generator, and the electrode, to deliver a continuous therapeutic signal at 0.5 Hz to 100 Hz with an overlapping high frequency pulse at 5 kHz to 10 kHz to the mammal,

wherein the processor is configured to synchronize phasing between the continuous therapeutic signal and the overlapping high frequency pulse,

wherein the overlapping high frequency pulse is configured to suppress sensitivity of pain receptors; and

wherein the signal is delivered at 30-200 mA.

2. The neuromodulation system of claim 1, wherein the mammal is a human.

3. The neuromodulation system of claim 1, wherein the signal is delivered at 85-100 mA.

4. The neuromodulation system of claim 1, wherein the overlapping high frequency pulse is a 10 kHz pulse.

5. The neuromodulation system of claim 1, wherein the overlapping high frequency pulse is a 5 kHz pulse.

6. The neuromodulation system of claim 1, wherein the delivered signal is applied paraspinally over a neck of the mammal.

7. The neuromodulation system of claim 6, wherein the neck of the mammal includes a cervical portion of a spinal cord and a brainstem.

8. The neuromodulation system of claim 1, wherein the delivered signal is applied paraspinally over a lower back of the mammal.

9. The neuromodulation system of claim 8, wherein the lower back includes at least one of a lumbar portion, a lumbosacral portion and a sacral portion of the spinal cord.

10. The neuromodulation system of claim 1, wherein the delivered signal is applied to a thoracic portion of a spinal cord or to an end organ.

11. The neuromodulation system of claim 10, wherein the thoracic portion of the spinal cord includes T11-T12 vertebrae.

12. The neuromodulation system of claim 1, wherein the mammal has a spinal cord injury which is classified as one of motor complete and motor incomplete.

13. The neuromodulation system of claim 1, wherein the mammal has an ischemic brain injury which is an injury from at least one of a stroke and acute trauma.

14. The neuromodulation system of claim 1, wherein the mammal has a neurodegenerative brain injury.

15. The neuromodulation system of claim 14, wherein the neurodegenerative brain injury is a brain injury associated with a condition selected from the group consisting of Parkinson'"'"'s disease, Huntington'"'"'s disease, Alzhiemers, ischemia, stroke, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS) or other neurological disorders such as cerebral palsey.

16. The neuromodulation system of claim 1, wherein the neuromodulatoin system is used to treat chronic pain, spasm, autonomic function, sexual function, vasomotor function, or cognitive function.

17. The neuromodulation system of claim 1, wherein the system induces motor activity which comprises at least one of standing, stepping, a walking motor pattern, sitting down, laying down, reaching, grasping, pulling, chewing, swallowing, sexual function, respiratory function, and pushing.

18. The neuromodulation system of claim 1, wherein the therapeutic signal and overlapping high frequency pulse are square waves and wherein the therapeutic signal and overlapping high frequency pulse are unequal values.

19. A neuromodulation system comprising:

a processor;

a first signal generator;

a second signal generator;

an electrode operatively connected to the processor; and

a memory device storing instructions, which when executed by the processor, causes the processor, in cooperation with the first signal generator, the second signal generator, and the electrode, to deliver a secondary high frequency electric pulse of 10 KHz which overlaps with a continuous therapeutic primary biphasic low frequency pulse delivered at 0.5 Hz to 100 Hz resulting in less skin impedance and pain free stimulation, wherein the signal is delivered at 30-200 mA;

wherein the processor is configured to synchronize phasing between the secondary high frequency electric pulse and continuous therapeutic primary biphasic low frequency pulse; and

wherein the secondary high frequency electric pulse is configured to suppress sensitivity of pain receptors.

20. The neuromodulation system of claim 19, wherein the primary biphasic low frequency pulse is delivered at 5-40 Hz.

21. The neuromodulation system of claim 19, wherein the delivered secondary high frequency electric pulse is applied paraspinally.