Spinal cord stimulation plus robotic walking training for chronic spinal cord injury

A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Robotic Gait Training in Trunk Muscle Activity and Walking Index in Chronic Spinal Cord Injury

This project will test whether adding non-invasive spinal cord stimulation to robotic gait training helps people with chronic incomplete spinal cord injury walk and move better and improve quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: National University Hospital, Singapore (Academic / other)
• Locations: 1 site (Singapore, Singapore)
• Trial ID: NCT05921175 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21–65 with incomplete (AIS B–D) traumatic spinal cord injury between 6 months and 5 years post-injury, levels C2–C8 or T1–L1, SCI-TCT score >13, not walking independently, and who are medically cleared for Ekso exoskeleton use and tSCS.

Not a fit: Patients unlikely to benefit include those with complete injuries (AIS A) or those with unstable medical conditions such as uncontrolled cardiopulmonary disease, uncontrolled autonomic dysreflexia, ventilator dependence, severe cognitive impairment, or severe spasms that prevent participation.

Why it matters

Potential benefit: If successful, adding tSCS to robotic gait training could improve walking function and quality of life for people with chronic incomplete spinal cord injury.

How similar studies have performed: Small pilot studies and early-phase trials combining spinal stimulation with gait training have shown promising improvements in stepping and voluntary movement, but the evidence is still limited and preliminary.

Eligibility criteria

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 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 Injury; spinal cord injury; transcutaneous spinal cord stimulation; robotic gait training