Spinal cord stimulation plus robotic walking training for chronic 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 study enrolling 12 adults with chronic incomplete traumatic spinal cord injury (six with paraplegia and six with tetraplegia). Each participant will complete 16 sessions of robotic gait training plus conventional physiotherapy over 8–10 weeks, have a one-week washout, then complete 16 sessions of robotic gait training with transcutaneous spinal cord stimulation (tSCS) plus physiotherapy over 8–10 weeks. Mobility, neuromuscular function, health-related quality of life, and participant satisfaction will be measured at baseline, after the first phase, and after the second phase. Training uses the EksoGT wearable exoskeleton and surface tSCS electrodes placed around the injury level with burst stimulation during gait practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Between 6 months to 5 years from the diagnosis of the traumatic SCI and who are not walking independently;
2. Age between 21 to 65 years old;
3. Incomplete spinal cord injury: ASIA Impairment Scale (AIS) Grade: B-D;
4. Spinal cord injury level: T1- L1, or C2-C8;
5. SCI-TCT Score \> 13;
6. Capable of providing an informed consent;
7. Cleared by Neurosurgeons/ Orthopeadic Surgeons for tSCS;
8. Meets prerequisites for Ekso wearable robotic exoskeleton training.

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. Skin conditions that limit the application of tSCS electrodes;
7. Active implanted medical devices that may be affected by tSCS;
8. Pregnant, planning to become pregnant or breastfeeding;
9. Concurrent participation in another drug or device trial that may interfere with this study;
10. Participated in wearable exoskeleton training within the last 3 months prior to enrolment.
11. Peripheral nerve injury or significant Lumbar Radiculopathy

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.