Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this 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.
Sponsor: Francis Farhadi
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Lexington
Source: ClinicalTrials.gov · NCT06520020 · last updated 2025-06-06