Spatiotemporal spinal stimulation to improve leg movement after a 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.