Safety of Transcutaneous Electrical Stimulation for Acute Spinal Cord Injury
This study is looking at whether a treatment called transcutaneous spinal cord stimulation (tSCS) using the ARC-EX device is safe and can help people recover movement after a recent spinal cord injury (SCI). The stimulation is delivered through electrodes placed on the skin. Researchers want to see if starting this treatment 3 days after injury is safe and if it helps improve movement. You could be eligible if you are an adult (21 years or older) with a traumatic, non-penetrating SCI that occurred within the last 12 hours, and your injury is classified as AIS Grade A, B, or C. This study plans to enroll 15 participants.
- Study design
- This is an interventional study with an unclear status, planning to enroll 15 participants. It involves comparing transcutaneous spinal cord stimulation with a sham (inactive) stimulation.
- What's involved
- You would undergo several tests before and after a single treatment, with assessments repeated before you go home around 7 days post-injury.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your motor scores will be measured from enrollment until the end of the study at 6 months follow-up.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety of Transcutaneous Electrical Stimulation Potentiating Recovery in Acute Spinal Cord Injury Syndromes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rajiv Saigal, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
- Anastasia V Keller, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Incidence of adverse eventsFrom enrollment to the end of treatment at 7 days post injury
Number of observed events over the transcutaneous spinal cord stimulation (tSCS) sessions. Examples of adverse events (AE) that will be carefully monitored * Hemodynamic instability * Skin irritation * Patient condition deterioration * Unanticipated AE
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor scoresFrom enrollment to the end of study at 6 months follow up
International Standards for Neurological Classification of SCI (ISNCSCI) motor scores; Standardized manual muscle testing is used to assess the strength of each key muscle, typically on a 6-point scale (0-5, 0 - total paralysis to 5 - normal strength with full ROM against gravity and maximal resistance); The motor score is derived by summing the individual muscle grades, with a maximum score of 50 for each upper and lower extremity, and a total maximum score of 100 for both limbs. Immediate change in scores with acute tSCS and change in scores from baseline to post treatment and at 6-month follow up will be assessed in the study.