Epidural stimulation for recovery in spinal cord injury patients
Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury
This study is testing if a special type of spinal cord stimulation can help people with severe spinal cord injuries improve their movement, standing, and overall body function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT03364660 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of lumbosacral spinal cord epidural stimulation (scES) on recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injuries. Thirty-six participants will receive targeted scES interventions designed for cardiovascular function, voluntary movement, or standing, with training tailored to each specific stimulation configuration. The study employs a novel approach by focusing on smaller cohorts and comprehensive assessments to better understand the mechanisms and efficacy of the interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-progressive spinal cord injuries who are at least 2 years post-injury and unable to voluntarily move their legs or stand.
Not a fit: Patients who are ventilator-dependent or have untreated severe musculoskeletal or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery of movement and autonomic function in patients with severe spinal cord injuries.
How similar studies have performed: Other studies have shown promise with similar epidural stimulation approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age * Non-progressive spinal cord injury * At least 2 years post injury * Stable medical condition * Unable to voluntarily move all individual joints of the legs * Unable to stand independently * Cardiovascular dysfunction including presence of persistent low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in a 24 hour period * Urodynamic dysfunction including dyssynergia and/or inability to void voluntarily and/or low voiding capacity * Respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes Exclusion Criteria: * Ventilator dependent * Untreated painful musculoskeletal dysfunction, fracture or pressure sore * Untreated psychiatric disorder or ongoing drug abuse * Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury * Bladder botox injections less than 12 months prior to implant * Colostomy bag, urostomy * Any implanted pump (i.e., baclofen pump, pain pump, etc) * Ongoing nicotine use * Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Where this trial is running
Louisville, Kentucky
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Susan J Harkema, PhD — University of Louisville
- Study coordinator: Susan J Harkema, PhD
- Email: susan.harkema@louisville.edu
- Phone: 502-582-7443
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.