NCT05921175 Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI
| NCT ID | NCT05921175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National University Hospital, Singapore |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2024-11-13 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone. This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with paraplegia and 6 subjects with tetraplegia will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks. Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1 and Post-Phase 2. A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.
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
Contact & Investigator
Gobinathan Chandran, MBBS
PRINCIPAL INVESTIGATOR
National University Hospital, Singapore
Frequently Asked Questions
Who can join the NCT05921175 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05921175 currently recruiting?
Yes, NCT05921175 is actively recruiting participants. Contact the research team at Gobinathan_CHANDRAN@nuhs.edu.sg for enrollment information.
Where is the NCT05921175 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT05921175 clinical trial?
NCT05921175 is sponsored by National University Hospital, Singapore. The principal investigator is Gobinathan Chandran, MBBS at National University Hospital, Singapore. The trial plans to enroll 6 participants.