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Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study

Study acronym: STIM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Jun 30, 2026 to Dec 1, 2027v5
  2. Primary completion date: Jun 30, 2025 to Jun 30, 2026
    • Study completion date: Dec 30, 2025 to Jun 30, 2026
    v4
  3. Lead sponsor: H. Francis Farhadi to Francis Farhadi
    • Study completion date: Jun 30, 2025 to Dec 30, 2025
    • Start date changed from estimate of Oct 2024 to Oct 23, 2024
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2024 to Oct 2024
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups: 1. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention. 2. Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 3. Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury.
Trial Details
NCT Number NCT06520020
Lead Sponsor Francis Farhadi
Conditions
(from sponsor)		 Spinal Cord Stimulation, Electric Stimulation Therapy, Traumatic Spinal Cord Injury, Cervical Myelopathy
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov