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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Francis Farhadi
Study ID
NCT06520020
Status
Recruiting
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Conditions

  • Cervical Myelopathy
  • Electric Stimulation Therapy
  • Spinal Cord Stimulation
  • Traumatic Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Spinal Cord Stimulation (Tc-SCS) — DEVICE
    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.

Study Details

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 Dates

Start date
Oct 23, 2024
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Non-Traumatic Spinal Cord Injury (ntSCI,) DCM - Progressive
    Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy (DCM) and offered surgical intervention. Prospective.
  • Experimental: Traumatic Spinal Cord Injury (tSCI) - Early/Acute
    Traumatic spinal cord injury (tSCI) screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 2-6 weeks after injury.
  • Active Comparator: Traumatic Spinal Cord Injury (tSCI) - Chronic
    Delayed traumatic spinal cord injury (tSCI) screened 6-24 months after acute cervical/thoracic spinal injury. The use of transcutaneous spinal cord stimulation (Tc-SCS) in chronic SCI delivered in the delayed timeframe is relatively well studied, and therefore will serve as the control arm.

Primary Outcome Measure

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [ Time Frame: Twelve Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kentucky - Chandler Medical CenterLexingtonKentucky40536-0298
Francis H Farhadi, MD, PhD
[email protected]
859-562-0247
Kris P Dyer, MPH, BS
[email protected]
859-323-4533

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By research site
University of Kentucky - Chandler Medical Center· Lexington, KY

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