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Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Age: = 18 years and = 80 years. * Written informed consent by patient and/or legal authorized representative (LAR). * No other life-threatening condition. * No evidence of sepsis. * No evidence of superficial skin infection at site of surgery and intervention. * An established diagnosis of either: * cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or * acute cervical / thoracic SCI with ASIA Impairment Scale grade A-D (as assessed within 72 hours of injury) with neurologic level of injury (NLI) from C2 to T12. * The ability to undergo, or have had, surgical intervention. -. The ability to undergo transcutaneous intervention including study procedures in the posterior cervical or thoracic midline at or after 14 days from surgery. Exclusion Criteria: * Any concomitant impairment of the upper and lower limb at baseline that could potentially confound the neurologic assessments; including but not limited to traumatic or disease conditions like brachial plexus injury, peripheral neuropathy, spinal hematoma, transverse myelitis, non-compressive myelopathy, dementia, and Parkinson's disease. * mJOA of \>= 15 and \<= 7, or AIS grade E tSCI at baseline assessment. * Currently involved in another non-observational ntSCI or tSCI study, or receiving another interventional drug, that could interfere with recordings and confound adverse events. * Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation, at discretion of the treating surgeon and/or principal investigator. * Unable to commit to the follow-up schedule. * Recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study. * Any condition likely to result in the patient's death within the next 12 months. * Prisoner. * Pregnancy. * Cardiac pacemaker dependent, unable to undergo electrical stimulation. * Brain implant, skull prosthesis, plate and screws limiting transcranial stimulation. * Tattoo at site of skin electrode that causes heat/pain during stimulation. * Subjects who in the opinion of the investigator are not suitable for inclusion in the study, with reason documented.
About the study
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.
What is being tested
- Transcutaneous Spinal Cord Stimulation (Tc-SCS) (device)
Sponsor: Francis Farhadi · Participants: 30 · Started: Oct 23, 2024
Contact the study team
- H. Francis Farhadi, MD, PhD · Phone: 859-323-5661
- Kris P Dyer, MPH, BS · Phone: 859-323-4533
Official record on ClinicalTrials.gov — NCT06520020
Locations in the U.S.
| Kentucky | University of Kentucky - Chandler Medical Center, Lexington |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.