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RECRUITING
NCT06520020
NA

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

Sponsor: Francis Farhadi

View on ClinicalTrials.gov

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

Interventions

DEVICE

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