Evaluating a new method of spinal cord stimulation for spinal cord injuries
Evaluating Safety and Feasibility of Transcutaneous Spinal Cord Stimulation Following Traumatic and Non-Traumatic Spinal Cord Injury: A Pilot Study
This study is testing a new way of using spinal cord stimulation to see if it is safe and helpful for people with different types of spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06520020 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the safety and feasibility of transcutaneous spinal cord stimulation (Tc-SCS) in patients with traumatic and non-traumatic spinal cord injuries. It will involve 30 participants divided into three groups based on the timing and nature of their spinal cord injury. The study will monitor autonomic and sensorimotor functions over a 12-month period, evaluating various functional measures at baseline and follow-up. The primary focus is to determine the safety of the Tc-SCS intervention and its potential clinical utility across different stages of spinal cord injury.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with either degenerative cervical myelopathy or acute cervical/thoracic spinal cord injuries.
Not a fit: Patients with other life-threatening conditions or significant impairments that could confound neurological assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for improving function and reducing pain in patients with spinal cord injuries.
How similar studies have performed: This study is novel as there are no reported clinical trials evaluating multi-modal outcomes of transcutaneous spinal cord stimulation for these specific spinal cord injury subtypes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lexington, Kentucky
- University of Kentucky - Chandler Medical Center — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Jared Wilcox, MD, PhD — University of Kentucky Neurosurgery
- Study coordinator: H. Francis Farhadi, MD, PhD
- Email: francis.farhadi@uky.edu
- Phone: 859-323-5661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.