Evaluating a new method of spinal cord stimulation for spinal cord injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cervical spinal cord stimulation for improving arm and hand function

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.