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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of transcutaneous spinal cord stimulation (Tc-SCS) using a non-significant risk device in patients with spinal cord injury (SCI). This study includes three groups: patients with non-traumatic SCI due to degenerative cervical myelopathy scheduled for surgery, patients with early traumatic SCI identified during hospital admission, and patients with delayed traumatic SCI 6 to 24 months post-injury serving as a control. The study aims to explore whether Tc-SCS can safely stimulate the injured spinal cord and improve neurological and functional outcomes. The intervention involves using a DS8R Biphasic Constant Current Stimulator to deliver electrical stimulation through bursts of biphasic rectangular pulses at specific frequencies and intensities tailored to elicit muscle responses in upper and lower limbs. Participants will receive this stimulation at defined intervals, with baseline and follow-up assessments over 12 months. The control group will receive stimulation in the chronic phase, which is relatively well studied. The study also includes perioperative and rehabilitation phases to assess the effects of stimulation alongside standard care. Participants will undergo various neurological and functional evaluations, including the International Standards for Neurological Classification of Spinal Cord Injury, ASIA Impairment Scale, modified Japanese Orthopaedic Association score, blood pressure monitoring, grip strength, walking tests, and patient-reported outcome measures like quality of life assessments. Safety and adherence will be tracked throughout the 12-month follow-up. The study collects data during hospital admission, rehabilitation, and clinical follow-up to measure the effects and feasibility of Tc-SCS in different SCI stages.
CONDITIONS
Brief 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
- Written informed consent by patient or legal authorized representative
- No other life-threatening condition
- No evidence of sepsis
- No superficial skin infection at site of surgery or intervention
- 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...
- Upper and lower limb impairments that may confound neurologic assessments (e.g., brachial plexus injury, peripheral neuropathy, spinal hematoma, transverse myelitis, non-compressive myelopathy, dementia, Parkinson's disease)
- Modified Japanese Orthopaedic Association score ≥ 15 or ≤ 7, or ASIA Impairment Scale grade E at baseline
- Participation in another interventional spinal cord injury study or treatment that may interfere
- Illness or mental disorder preventing accurate medical/neurological evaluation
- Inability to commit to follow-up schedule
- Recent regular substance abuse that may interfere with participation
- Conditions likely to cause death within 12 months
- Prisoner status
- Pregnancy
- Dependent on cardiac pacemaker or unable to undergo electrical stimulation
- Brain implant, skull prosthesis, or hardware limiting transcranial stimulation
- Tattoo at electrode site causing heat or pain during stimulation
- Any condition deemed unsuitable by investigator with documented reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive transcutaneous spinal cord stimulation (Tc-SCS) to assess its safety and impact on sensorimotor and autonomic function following traumatic or non-traumatic spinal cord injury.
Multiple visits during admission, rehabilitation, and clinical follow-up over 12 months
Duration - Up to 12 months
Participants are monitored for safety, neurological outcomes, and functional improvements after completion of the stimulation treatment.
Visits at established follow-up timepoints across 12 months
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
K
Kris P Dyer, MPH, BS
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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