A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

Inclusion Criteria:

Male or Female subjects

1. At least 18 years old and no older than 70 years old at the time of enrollment.

2. Able-bodied subjects

3. Traumatic spinal cord injury

4. Upper limb target: neurological level at or above Thoracic 1 level, AbbreviatedInjury Scale (AIS) B, C or D impairment grade, primary non-ambulatory;

• Lower limb target: neurological level at or above Thoracic 10 level, withresidual lower limb function; AIS B, C or D impairment grade primary couldambulate;

• Trunk target: neurological at or above Thoracic 5, AIS A, B, C or D impairmentgrade, primary wheelchair user

5. Spinal cord injury sustained more than 6 months prior to study.

6. Movement/excitability/etc:

• Upper limb target: Has detectable residual connection in upper-limb muscles inat least one side confirmed by voluntary electromyography (EMG) or detectablemotor evoked potential (MEP) and a visible contraction when functionalelectrical stimulation (FES) is applied in the hand or wrist muscle atbaseline.

• Lower limb target: Has detectable residual connection in lower-limb muscles inat least one side confirmed by voluntary EMG or detectable MEP and a visiblecontraction when FES is applied in lower limb ankle plantar or dorsiflexormuscle at baseline.

• Trunk target: Has detectable residual connection in trunk muscles in at leastone side confirmed by voluntary EMG or detectable MEP and a visible contractionwhen FES is applied in trunk muscle at baseline.

7. Able to commit to intervention and assessment sessions over a maximum duration of 2months.

Exclusion Criteria:

1. Has traumatic brain injury, stroke, multiple sclerosis, or other disorders thatcould affect neuromotor function.

2. Has severe spasticity that could prevent the study protocol as determined by theinvestigator.

3. Has major executive dysfunction, dementia, depression, neurocognitive impairments,or other major medical co-morbidities.

4. Has contraindications for transcutaneous stimulation using FES or TSCS such asbreakdown of skin in the area that will come into contact with electrodes,thrombosis, or skin disease.

5. Has a poorly managed autonomic dysreflexia that could be triggered by transcranialmagnetic stimulation (TMS), FES, or TSCS.

6. Has a history of prior intracranial surgery or known medical risks that would limitTMS protocols.

7. Has a history of epilepsy, convulsion or seizures.

8. Individuals with metal implants in their head or spine near the sites to bestimulated and other implantable devices (e.g., cochlear implants) in the body thatcould be affected by TMS or TSCS.

9. Has implanted neurostimulator (e.g., deep brain stimulation (DBS),epidural/subdural, vagal nerve stimulation or VNS).

10. Has a cardiac pacemaker or intracardiac lines.

11. Has peripheral neuropathy, including diabetic polyneuropathy and entrapmentneuropathy.

12. Has urinary tract infection, unhealed fracture, contracture, and pressure sore asdetermined by Braden Scale value of 14 and below.

13. Individuals who require therapy or other care that could interfere withparticipation in the study.

14. Individuals on investigational drugs or any other intervention known to have apotential impact on neuromotor function.

15. Individuals with substance disorders, including alcoholism and drug abuse.

16. Individuals who are pregnant, breastfeeding, or the desire to become pregnant duringthe study.

17. In the opinion of the investigators, the study is not safe or appropriate for theparticipant.