High density epidural stimulation for facilitation of locomotion, posture, voluntary movement, and recovery of autonomic, sexual, vasomotor, and cognitive function after neurological injury

• US 9,907,958 B2
• Filed: 07/02/2015
• Issued: 03/06/2018
• Est. Priority Date: 01/03/2011
• Status: Active Grant

• Current Assignee: California Institute of Technology, Regents of the University of California (University of California), University of Louisville
• Original Assignee: California Institute of Technology, Regents of the University of California (University of California), University of Louisville
• Inventors: Edgerton, Victor Reggie, Roy, Roland R., Gerasimenko, Yury, Burdick, Joel W., Harkema, Susan J., Hodes, Jonathan, Tai, Yu-Chong, Nandra, Mandheerej S., Angeli, Claudia A., Desautels, Thomas Anthony
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/790,729
• Publication Number:
  US 20160030748A1
• Time in Patent Office: 978 Days
• Field of Search: 607 48, 607 49, 607 70, 607117
• CPC Class Codes: A61H 1/0237 for the lower limbs
• CPC Class Codes: A61H 1/0274 for the upper limbs
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A63B 21/00181 comprising additional means assisting the user to overcome part of the resisting force, i.e. assisted-active exercising
• CPC Class Codes: A63B 22/0235 driven by a motor
• CPC Class Codes: A63B 2213/004 with electrotherapy
• CPC Class Codes: A63B 2220/805 Optical or opto-electronic sensors
• CPC Class Codes: A63B 2230/60 muscle strain, i.e. measured on the user
• CPC Class Codes: A63B 69/0064 Attachments on the trainee preventing falling
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

Methods of enabling locomotor control, postural control, voluntary control of body movements (e.g., in non-weight bearing conditions), and/or autonomic functions in a human subject having spinal cord injury, brain injury, or neurological neuromotor disease are described.

Claims

1. A method comprising:

applying an electrical stimulation to a portion of a spinal cord of a neurologically paralyzed patient in conjunction with physical training of a paralyzed portion of the neurologically paralyzed patient, and

administering one or more neuropharmaceutical agents to the neurologically paralyzed patient,

wherein the electrical stimulation is below an amount that fully activates a spinal circuit such that the spinal circuit is at least partially activatable by the addition of supraspinal signals.

2. The method of claim 1, wherein the neurologically paralyzed patient has a motor complete paralysis or a motor incomplete paralysis.

3. The method of claim 1, wherein the electrical stimulation does not directly activate muscle cells in the paralyzed portion of the patient'"'"'s body.

4. The method of claim 1, wherein the physical training provides induced neurological signals, and the induced neurological signals comprise at least one of postural proprioceptive signals, locomotor proprioceptive signals, and the supraspinal signals.

5. The method of claim 1, wherein the neurologically paralyzed patient has a spinal cord injury classified as motor complete or motor incomplete.

6. The method of claim 1, wherein the neurologically paralyzed patient had an ischemic brain injury, a traumatic brain injury, or a neurodegenerative brain injury.

7. The method of claim 6, wherein the neurodegenerative brain injury is associated with at least one of Parkinson'"'"'s disease, Huntington'"'"'s disease, Alzheimer'"'"'s, ischemia, stroke, amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), and cerebral palsy.

8. The method of claim 1, wherein the applying the electrical stimulation is by an electrode array that is implanted epidurally at the spinal cord of the patient.

9. The method of claim 1, wherein the physical training comprises at least one of standing, stepping, reaching, moving one or both legs, moving one or both feet, grasping, and stabilizing sitting posture.

10. The method of claim 1, wherein the applying the electrical stimulation:

enables voluntary movement of muscles involved in at least one of standing, stepping, reaching, grasping, voluntarily changing positions of one or both legs, voiding the patient'"'"'s bladder, voiding the patient'"'"'s bowel, postural activity, and locomotor activity,

enables or improves autonomic control of at least one of cardiovascular function, body temperature, and metabolic processes, or

facilitates recovery of at least one of an autonomic function, sexual function, vasomotor function, and cognitive function.

11. The method of claim 1, wherein the neuropharmaceutical agent is a serotonergic drug, a dopaminergic drug, a noradrenergic drug, a GABAergic drug, a glycinergic drug, or a combination thereof.

12. A method of enabling one or more bodily functions in a neurologically paralyzed patient, the method comprising:

stimulating the spinal cord of the neurologically paralyzed patient using an electrode array while subjecting the neurologically paralyzed patient to physical training, and

administering one or more neuropharmaceutical agents to the neurologically paralyzed patient,

wherein at least one of the stimulating or physical training activates at least one spinal circuit by at least one of supraspinal information and proprioceptive information derived from the region of the neurologically paralyzed patient where the one or more bodily functions occur.

13. The method of claim 12, wherein the one or more bodily functions is selected from postural and/or locomotor activity, voluntary movement of leg position when not bearing weight, voluntary voiding of the bladder and/or bowel, return of sexual function, autonomic control of cardiovascular function, body temperature control, normalized metabolic processes, or a combination thereof.

14. The method of claim 12, wherein the region where the region of the neurologically paralyzed patient where the one or more bodily functions occur are lower limbs or upper limbs.

15. The method of claim 12, wherein the physical training comprises at least one of standing, stepping, sitting down, laying down, reaching, grasping, stabilizing sitting posture, and stabilizing standing posture.

16. The method of claim 12, wherein the electrode array comprises one or more electrodes stimulated in a monopolar configuration or bipolar configuration.

17. The method of claim 12, wherein the stimulating comprises at least one of tonic stimulation and intermittent stimulation.

18. The method of claim 12, wherein the physical training comprises inducing a positional or physical change in a region of the neurologically paralyzed patient.

19. The method according to claim 18, wherein the positional or physical change in the neurologically paralyzed patient comprises at least one of standing, stepping, reaching, and grasping.

20. The method of claim 12, wherein the one or more neuropharmaceutical agents comprises a serotonergic drug, a dopaminergic drug, a noradrenergic drug, a GABAergic drug, a glycinergic drug, or a combination thereof.