NCT06520020 Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
| NCT ID | NCT06520020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Francis Farhadi |
| Condition | Spinal Cord Stimulation |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-10-23 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Jared Wilcox, MD, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky Neurosurgery
Frequently Asked Questions
Who can join the NCT06520020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Spinal Cord Stimulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06520020 currently recruiting?
Yes, NCT06520020 is actively recruiting participants. Contact the research team at francis.farhadi@uky.edu for enrollment information.
Where is the NCT06520020 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT06520020 clinical trial?
NCT06520020 is sponsored by Francis Farhadi. The principal investigator is Jared Wilcox, MD, PhD at University of Kentucky Neurosurgery. The trial plans to enroll 30 participants.