NCT06596174 Effect of tSCS on Ankle Movement Training in Individuals With SCI
| NCT ID | NCT06596174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung University |
| Condition | SCI - Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2026-08 |
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 80 participants in total. It began in 2024-11-25 with a primary completion date of 2026-08.
⚠ 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 clinical trial explores the effectiveness of transcutaneous spinal cord stimulation (tSCS), a non-invasive technique, in facilitating spinal circuitry adaptation in individuals with spinal cord injury (SCI). While epidural spinal cord stimulation (eSCS) has shown functional benefits, its application is limited by the side effects associated with implanted electrodes. tSCS, which shares a similar mechanism but does not require surgery, has yet to be extensively studied in large human trials. The study aims to: Determine optimal tSCS parameters for non-invasive spinal stimulation. Investigate the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training. Examine the long-term clinical outcomes of combining tSCS with ankle movement training in individuals with incomplete SCI. The trial will include both healthy participants and individuals with complete and incomplete SCI, using the soleus post-activation depression (PAD) model to evaluate spinal circuitry adaptation. The results will provide insights into spinal re-adaptation and potentially introduce a novel, non-invasive approach for SCI rehabilitation.
Eligibility Criteria
Health subjects: Exclusion Criteria: 1. Musculoskeletal injuries on legs. 2. Osteoporosis. SCI subjects: Inclusion Criteria 1\. Participants with chronic spinal cord injury, with injury duration greater than one year. Exclusion Criteria 1. Current musculoskeletal or joint injuries in the lower limbs. 2. History of central or peripheral neuromuscular diseases. 3. Presence of a pacemaker. 4. Current use of antispastic or antidepressant medications. 5. Current venous thromboembolism or osteoporosis. 6. Impairment of the soleus H-reflex arc.
Frequently Asked Questions
Who can join the NCT06596174 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying SCI - 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 NCT06596174 currently recruiting?
Yes, NCT06596174 is actively recruiting participants. Visit ClinicalTrials.gov or contact Chang Gung University to inquire about joining.
Where is the NCT06596174 trial being conducted?
This trial is being conducted at Taoyuan, Taiwan.
Who is sponsoring the NCT06596174 clinical trial?
NCT06596174 is sponsored by Chang Gung University. The trial plans to enroll 80 participants.