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Recruiting NCT07397559

NCT07397559 Spatiotemporal tSCS in Spinal Cord Injury

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Clinical Trial Summary
NCT ID NCT07397559
Status Recruiting
Phase
Sponsor Washington University School of Medicine
Condition Spinal Cord Injuries (SCI)
Study Type INTERVENTIONAL
Enrollment 48 participants
Start Date 2026-01-19
Primary Completion 2030-08-31

Eligibility & Interventions

Sex All sexes
Min Age 16 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
No StimulationConventional tSCSSpatiotemporal tSCS

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

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 48 participants in total. It began in 2026-01-19 with a primary completion date of 2030-08-31.

⚠ 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

Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.

Eligibility 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

Contact & Investigator

Central Contact

Ismael Seáñez, PhD

✉ ismaelseanez@wustl.edu

📞 314-935-7665

Frequently Asked Questions

Who can join the NCT07397559 clinical trial?

This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying Spinal Cord Injuries (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07397559 currently recruiting?

Yes, NCT07397559 is actively recruiting participants. Contact the research team at ismaelseanez@wustl.edu for enrollment information.

Where is the NCT07397559 trial being conducted?

This trial is being conducted at St Louis, United States.

Who is sponsoring the NCT07397559 clinical trial?

NCT07397559 is sponsored by Washington University School of Medicine. The trial plans to enroll 48 participants.

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