Transcutaneous spinal stimulation plus robotic arm training for people with cervical spinal cord injury

A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Upper Limb Robotics Training in Upper Limb Rehabilitation in Patients With Tetraplegic Spinal Cord Injury

This project will try adding transcutaneous spinal cord stimulation (tSCS) to robotic arm therapy to see if it improves arm and hand function in adults with chronic incomplete cervical spinal cord injuries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: National University Hospital, Singapore (Academic / other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT07432321 on ClinicalTrials.gov

What this trial studies

This is a prospective single-arm crossover pilot at Alexandra Hospital in Singapore enrolling about 6–8 adults with chronic incomplete traumatic cervical spinal cord injuries (C2–C8). Participants complete Phase 1 of 16 sessions of upper-limb robotic training plus conventional occupational therapy over 8–10 weeks, then after a one-week washout complete Phase 2 of 16 sessions of robotic training combined with tSCS and occupational therapy over 8–10 weeks. The study uses the H-Man robotic arm and EsoGlove hand system and collects mobility, neuromuscular, health-related quality-of-life, and satisfaction measures at baseline, after each phase, and at a four-week follow-up. As a small single-center pilot, the aim is to test feasibility and look for signals of benefit rather than provide definitive efficacy conclusions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21–80 who are 6 months to 5 years post traumatic incomplete cervical (C2–C8) spinal cord injury, with ISNCSCI UEMS >25, pinch force >25 N, grasp force >100 N, ability to perform the box-and-block test, at least one hour sitting tolerance, and surgical clearance for tSCS.

Not a fit: People with uncontrolled cardiopulmonary disease, unstable autonomic dysreflexia, ventilator dependence, severe cognitive impairment, uncontrolled severe spasticity that prevents participation, or other unstable medical conditions are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, adding tSCS to robotic upper-limb training could improve arm and hand function and related quality of life for people with chronic incomplete cervical spinal cord injury.

How similar studies have performed: Prior small studies combining spinal stimulation with activity-based rehabilitation have shown promising motor improvements, but noninvasive tSCS specifically paired with upper-limb robotic training is still limited and exploratory.

Eligibility criteria

Inclusion Criteria:

1. At least 6 months to 5 years from the diagnosis of the traumatic SCI;
2. Participants between 21 and 80 years of age;
3. C2-8 level injuries;
4. ISNCSCI-UEMS \>25,
5. Pinch force \> 25 N;
6. Grasp force \> 100 N;
7. Able to perform the box and block test;
8. Sitting tolerance for at least 1 hour (No known postural hypotension issues or pressure intolerance);
9. Capable of providing an informed consent;
10. Cleared by Neurosurgeons/Orthopaedic Surgeon for tSCS;

Exclusion Criteria:

1. Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator.
2. Participant has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound performance and outcomes like uncontrolled neuropathic pain, depression, severe cognitive impairment.
3. Unstable or uncontrolled autonomic dysreflexia.
4. Requires ventilator support.
5. Spasms that limit the ability of the subjects to participate in the study training as determined by the investigator.
6. Has an autoimmune etiology of spinal cord dysfunction/injury
7. History of additional neurologic disease, such as stroke, multiple sclerosis and traumatic brain Injury.
8. Pain in shoulder and/or hand which will be inhibitory towards rehabilitative therapy.
9. Severe Upper limb contractures.
10. Acute Medical conditions to Upper limb (ie Fractures that would limit ROM and/or weightbearing).
11. Participants who are pregnant.

Where this trial is running

Singapore, Singapore

• Alexandra Hospital — Singapore, Singapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Gobinathan Chandran, MBBS — National University Hospital, Singapore
• Study coordinator: Gobinathan Chandran, MBBS

Conditions Spinal Cord Injuries; spinal cord injury; transcutaneous spinal cord stimulation; upper limb robotic training