Long-term effects of epidural stimulation for spinal cord injury recovery
Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
This study tests if long-term spinal cord stimulation can help people with chronic spinal cord injuries regain voluntary movement over ten years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05705453 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term effects of chronic spinal cord stimulation on restoring voluntary movement in patients with chronic spinal cord injuries. Participants will be enrolled for a decade and will attend assessments biannually in Minneapolis, where they will undergo various programming settings of their spinal cord stimulators. The goal is to determine the efficacy of epidural stimulation in improving motor function over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with stable spinal cord injuries below the C5 level and who have a functional implanted spinal cord stimulator.
Not a fit: Patients who are dependent on opioids for pain management or have conditions that prevent full participation in rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this could significantly enhance mobility and quality of life for individuals with chronic spinal cord injuries.
How similar studies have performed: Other studies have shown promising results with spinal cord stimulation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 22 years of age or older * Able to undergo the informed consent process * Stable spinal cord injury * International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5 * No ventilator dependency within the last year * American Spinal Injury Association (AISA) imparement scale"A" or "B" in the absence of spinal cord stimulation * Medically stable in the judgment of the Principal investigator * Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery * Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation * Spinal imaging of the stimulator system Exclusion Criteria: * Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator * Use of botulinum toxin (Botox) injections in the previous six months * Clinically significant mental illness in the judgment of the principal investigator * Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator * Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI * Current Pregnancy * Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.
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.