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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Alexandra Hospital
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Gobinathan Chandran, MBBS — National University Hospital, Singapore
• Study coordinator: Gobinathan Chandran, MBBS
• Email: Gobinathan_CHANDRAN@nuhs.edu.sg
• Phone: (65) 94575924

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.