Actively Recruiting
Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
Led by Francis Farhadi · Updated on 2025-06-06
30
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Provided written informed consent by patient or legal authorized representative
- No life-threatening condition
- No signs of sepsis
- No superficial skin infection at surgery or intervention site
- Diagnosis of cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or acute cervical/thoracic spinal cord injury with ASIA Impairment Scale grade A-D and neurologic level of injury from C2 to T12
- Ability to undergo or have undergone surgical intervention
- Ability to undergo transcutaneous intervention at or after 14 days from surgery
You will not qualify if you...
- Any impairment of upper or lower limbs at baseline that could affect neurological assessments, including brachial plexus injury, peripheral neuropathy, spinal hematoma, transverse myelitis, non-compressive myelopathy, dementia, or Parkinson's disease
- Modified Japanese Orthopaedic Association score less than 8 or greater than or equal to 15, or ASIA Impairment Scale grade E at baseline
- Participation in another non-observational spinal cord injury study or receiving an interventional drug that could interfere with study results
- Illness or mental disorder that may prevent accurate medical or neurological evaluation
- Inability to commit to follow-up schedule
- Recent history of substance abuse
- Any condition expected to cause death within 12 months
- Prisoner status
- Pregnancy
- Cardiac pacemaker dependence preventing electrical stimulation
- Brain implant, skull prosthesis, or hardware limiting transcranial stimulation
- Tattoo at electrode site causing heat or pain during stimulation
- Investigator's judgment deeming participant unsuitable for study inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Kentucky - Chandler Medical Center
Lexington, Kentucky, United States, 40536-0298
Actively Recruiting
Research Team
H
H. Francis Farhadi, MD, PhD
CONTACT
K
Kris P Dyer, MPH, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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