Multi-site transcutaneous electrical stimulation of the spinal cord for facilitation of locomotion

• US 9,993,642 B2
• Filed: 03/14/2014
• Issued: 06/12/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Gerasimenko, Yury, Edgerton, Victor Reggie, Roy, Roland R., Lu, Daniel C.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US14/775,618
• Publication Number:
  US 20160030737A1
• Time in Patent Office: 1,551 Days
• Field of Search: 607 48
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/197 the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid carnitine A61K31/205
• 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 1/36034 specified by the stimulation parameters
• CPC Class Codes: A63B 2213/004 with electrotherapy
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Abstract

In various embodiments, non-invasive methods to induce motor control in a mammal subject to spinal cord or other neurological injuries are provided. In some embodiments the methods involve administering transcutaneous electrical spinal cord stimulation (tSCS) to the mammal at a frequency and intensity that induces locomotor activity.

Claims

1. A method of facilitating locomotor activity in a mammal having a spinal cord or brain injury, said method comprising administering transcutaneous electrical stimulation to the spinal cord of said mammal at a frequency and intensity that facilitates the recovery or improved control of said locomotor activity, wherein said stimulation is applied at two or more locations over the spinal cord, stimulates spinal circuitry, and enables or induces a locomotor pattern in said mammal.

2. The method of claim 1, wherein said mammal is a human.

3. The method of claim 2, wherein said transcutaneous electrical spinal cord stimulation is applied paraspinally over C4-C5, T11-T12 and/or L1-L2 vertebrae.

4. The method of claim 1, wherein said transcutaneous stimulation is applied at an intensity ranging from about 30 to 200 mA.

5. The method of claim 1, wherein said transcutaneous stimulation is applied at a frequency ranging from about 3 Hz to about 100 Hz.

6. The method of claim 1, wherein said mammal has a spinal cord injury and/or an ischemic brain injury, and/or a neurodegenerative brain injury.

7. The method of claim 6, wherein said mammal has a spinal cord injury clinically classified as motor complete.

8. The method of claim 6, wherein said mammal has a spinal cord injury clinically classified as motor incomplete.

9. The method of claim 6, wherein said mammal has an ischemic brain injury brain injury from stroke or acute trauma.

10. The method of claim 6, wherein said mammal has a neurodegenerative brain injury associated with a condition selected from the group consisting of Parkinson'"'"'s disease, Huntington'"'"'s disease, Alzheimer'"'"'s, ischemic stroke, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and cerebral palsy.

11. The method of claim 1, wherein said locomotor activity comprises one or more activities selected from the group consisting of standing, stepping, speech, swallowing or breathing, a walking motor pattern, sitting down, and laying down.

12. The method of claim 1, wherein said mammal is a human and the stimulation is under control of said human.

13. The method of claim 1, wherein said method further comprises physical training of said mammal.

14. The method of claim 13, wherein said physical training comprises inducing a load bearing positional change in said mammal, and/or standing, and/or stepping.

15. The method of claim 13, wherein said physical training comprises robotically guided training.

16. The method of claim 1, wherein said method further comprises administration of one or more neuropharmaceuticals.

17. The method of claim 16, wherein said neuropharmaceutical comprises one or more agents selected from the group consisting of a serotonergic drug, a dopaminergic drug, and a noradrenergic drug.

18. The method of claim 1, wherein said transcutaneous electrical spinal cord stimulation is administered to two or more spinal levels simultaneously.

19. The method of claim 18, wherein said two or more spinal levels comprise spinal levels selected from the group consisting of the brain stem, cervical, thoracic, thoraco-lumbar, lumbar, lumbo-sacral, and sacrum.

20. The method of claim 1, wherein said method enables voluntary movement of muscles involved in at least one of standing, stepping, reaching, grasping, voluntarily changing positions of one or both legs.

21. The method of claim 1, wherein said transcutaneous stimulation is applied at a frequency ranging from about 5 Hz to about 40 Hz.

22. The method of claim 1, wherein said transcutaneous stimulation is applied at an intensity ranging from about 20 mA to about 100 mA.

23. The method of claim 1, wherein said transcutaneous stimulation is provided on a high frequency carrier of about 10 kHz.