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Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
Sponsor: Francis Farhadi
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-10-23
Completion Date
2026-06-30
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
Transcutaneous Spinal Cord Stimulation (Tc-SCS)
This study will employ a DS8R Biphasic Constant Current Stimulator (Digitimer, Hertfordshire, United Kingdom) to administer transcutaneous (Tc) SCS through bursts of biphasic rectangular pulses, each lasting 400 μs to 1 ms, at 30 Hz frequency on a carrier frequency is 10 kHz. The intensity of stimulation will be 120% the threshold intensity that elicits visible twitch or motor evoked potential (MEP) triggered in the biceps brachii (BB) or abductor pollicis brevis (APB) muscle for upper extremity, and quadriceps femoris (QF) or tibialis anterior (TA) in the lower extremity.
Locations (1)
University of Kentucky - Chandler Medical Center
Lexington, Kentucky, United States