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Clinical trial Recruiting at 1 site Interventional Ages 21 and up

Transcutaneous spinal cord stimulation to enhance recovery after acute spinal cord injury

Official title: Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes

Run by University of California, San Francisco · NCT07090473 · Data updated 2026-11-12

Tests whether non-invasive electrical stimulation applied to the spine starting three days after a traumatic acute spinal cord injury is safe and can help people regain movement.

More Spinal Cord Injuries (SCI) trials

Quick facts

Study typeInterventional
Ages21 Years and up
SexAll
Enrollment15 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (San Francisco, California)
StatusRecruiting
StartedApril 10, 2026
Main results expectedJune 30, 2028
Study endsJune 30, 2028
Registry record updatedJune 4, 2026
Trial IDNCT07090473 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults (≥18) with acute traumatic cervical or thoracic SCI (C4–T10) presenting within 12 hours, classified AIS A–C, who are admitted to the ICU with a lumbar drain in place.

Probably not a fit

Patients with AIS D or E, penetrating injuries or complete cord transection, pregnancy, incarceration, class 2–3 obesity, or other exclusionary conditions are not eligible and therefore unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This combined Phase 1/2 pilot enrolls patients with recent traumatic cervical or thoracic spinal cord injury and delivers transcutaneous spinal cord stimulation (tSCS) beginning 72 hours after injury during the hospital/ICU stay. In the initial phase participants undergo baseline motor and sensory exams, blood and CSF sampling, neurophysiologic recordings, then receive a single 60-minute continuous tSCS treatment with pre- and post-treatment assessments and a re-assessment around day 7. A sham stimulation arm is included to compare safety signals and short-term physiologic effects, with close monitoring of hemodynamics and spinal cord perfusion pressure. Outcomes include ISNCSCI/AIS motor and sensory measures, neurophysiologic markers, biomarker changes, and adverse events to determine whether early tSCS can be safely implemented and shows signals of benefit.

Why it matters

Potential benefit: If successful, early tSCS could help preserve or improve motor and sensory recovery after acute traumatic spinal cord injury and reduce long-term disability.

How similar studies have gone: Non-invasive spinal stimulation has shown promising motor gains in chronic SCI, but applying tSCS within days after acute traumatic SCI is relatively novel and largely untested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

A subject will be eligible for enrollment in the study of the following criteria apply:

1. Written informed consent is obtained.
2. Acute traumatic cervicothoracic SCI that meets all of the following criteria:

   1. Acute SCI presenting to the hospital within 12 hours of injury
   2. Traumatic non-penetrating SCI
   3. American Impairment Scale (AIS) Grade A, B, or C
   4. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological level of injury between C4 and T10
3. Aged \>/=18 years
4. Admission to Intensive Care Unite (ICU) with lumbar drain in place per standard of care

Exclusion Criteria:

A subject will not be eligible for this study if ANY of the following criteria apply:

1. Subjects classified as AIS D or E
2. Penetrating SCIs or complete transection of the spinal cord
3. Pregnancy
4. Incarceration or police custody
5. Class 2 or Class 3 obesity
6. Any concomitant injury that, in the judgment of the Investigator, interferes with the procedures and examinations required by the study protocol, including but not limited to:

   1. multiple spinal cord lesions
   2. fractures requiring lower extremity casts or splints
   3. skin breakdown or burns over the lumbar spine
   4. profound hemodynamic instability
   5. traumatic brain injury (defined by Glasgow Coma Scale (GCS) \<14 at enrollment or inability to participate in exam)

Where it's running

  • Zuckerberg San Francisco General Hospital
    San Francisco, California, United States     Recruiting

Study contacts

  • Principal investigator: Rajiv Saigal, MD, PhD — University of California, San Francisco
  • Study coordinator: Clinical Research Coordinator
  • Email: tracksci@ucsf.edu
  • Phone: 628-206- 3859

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
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Acute Spinal Cord Injury (SCI) 3University of California, San Francisco 3127
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.