Epidural stimulation to improve movement and autonomic function after spinal cord injury
Epidural Stimulation for Spinal Cord Injury
This study is testing if epidural stimulation can help people with complete spinal cord injuries improve their movement and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT03026816 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of epidural spinal cord stimulation (SCS) to enhance voluntary movement and autonomic function in individuals with complete spinal cord injuries. It aims to optimize stimulation parameters through a clinical decision support system, exploring the effects on cardiovascular health, urinary function, psychiatric outcomes, and overall quality of life. The research builds on existing knowledge of SCS for pain management, applying it to a new population with significant variability in outcomes. By establishing the disinhibitory effects of SCS, the study seeks to provide a comprehensive understanding of its benefits for patients with chronic spinal cord injury.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with stable, motor-complete paraplegia due to discrete spinal cord injuries between C6 and T10.
Not a fit: Patients with significant dysautonomia or other serious comorbidities that complicate spinal cord injury surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve voluntary movement and autonomic function in patients with spinal cord injuries.
How similar studies have performed: Preliminary evidence suggests that similar approaches using spinal cord stimulation have shown promise, but this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 22 years of age or older * Able to undergo the informed consent/assent process * Stable, motor-complete paraplegia * Discrete spinal cord injury between C6 and T10 * ASIA A or B Spinal Cord Injury Classification * Medically stable in the judgement of the principal investigator * Intact segmental reflexes below the lesion of injury * Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation * Willing to attend all scheduled appointments Exclusion Criteria: * Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues) * Inability to withhold antiplatelet/anticoagulation agents perioperatively * Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP \< 50 or \>200. * Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator * Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator * Clinically significant mental illness in the judgement of the principal investigator * Botulinum toxin injections in the previous 6 months * Volitional movements present during EMG testing in bilateral lower extremities * Unhealed spinal fracture * Presence of significant contracture * Presence of pressure ulcers * Recurrent urinary tract infection refractory to antibiotics * Current Pregnancy
Where this trial is running
Minneapolis, Minnesota
- Hennepin County Medical Center — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: David Darrow, MD — University of Minnesota
- Study coordinator: Study Coordinator
- Email: estand@umn.edu
- Phone: 612-873-9113
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.