Transcutaneous spinal cord stimulation to enhance recovery after acute spinal cord injury
Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07090473 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Francisco, California
- 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
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.