Spatiotemporal spinal stimulation to improve leg movement after a spinal cord injury
Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI
This project tests whether changing the location, frequency, and intensity of non-invasive spinal stimulation can more precisely activate leg muscles in people with chronic spinal cord injury who can still voluntarily contract some leg muscles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07397559 on ClinicalTrials.gov |
What this trial studies
This interventional protocol uses non-invasive transcutaneous spinal cord stimulation (tSCS) with varying spatial, frequency, and amplitude settings while participants perform leg movements. Participants with chronic spinal cord injury who can voluntarily contract at least two leg muscles will receive no stimulation, conventional tSCS, and spatiotemporal tSCS configurations in controlled sessions. Outcomes will include measures of muscle recruitment patterns, torque generation, and any pain experienced under each stimulation parameter set. The goal is to map how different stimulation parameters selectively engage neural pathways and muscle groups to guide more personalized rehabilitation strategies.
Who should consider this trial
Good fit: Ideal candidates are people aged 16–65 with chronic (≥1 year) spinal cord injury at levels C3–T12, classified AIS C or D, who can voluntarily contract at least two leg muscles and can communicate pain or follow instructions.
Not a fit: Patients with progressive spinal lesions, implanted stimulators or cardiac devices, uncontrolled cardiopulmonary disease, pregnancy, or those unable to voluntarily contract leg muscles are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could enable more targeted, personalized non-invasive stimulation therapies that help restore specific leg functions while preserving residual movement.
How similar studies have performed: Non-invasive tSCS combined with training has shown promising improvements in posture, walking, and hand function in prior work, but using detailed spatiotemporal parameter control to selectively target muscles is a newer approach with limited but encouraging preliminary data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 16 and 65 years. 2. Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment. 3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D 4. Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction). 5. Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks 6. Able to provide consent 7. Ability to follow multiple instructions and communicate pain or discomfort Exclusion Criteria: 1. Progressive spinal lesions, including degenerative disorders of the spinal cord 2. Pregnant, planning to become pregnant, or currently breastfeeding 3. History of cardiopulmonary disease or cardiac symptoms 4. Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.) 5. Presence of orthopedic conditions that would negatively affect participation in leg exercise 6. History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled 7. Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders 8. Spasms that limit the ability to participate in leg exercise activity 9. Breakdown in skin area that will be in contact with electrodes
Where this trial is running
St Louis, Missouri
- Washington University, St. Louis — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Ismael Seáñez, PhD
- Email: ismaelseanez@wustl.edu
- Phone: 314-935-7665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.