NCT05705453 Epidural Stimulation After Neurologic Damage: Long-Term Outcomes
| NCT ID | NCT05705453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | SCI - Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-05-11 |
| Primary Completion | 2033-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-05-11 with a primary completion date of 2033-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
Eligibility 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.
Contact & Investigator
David Darrow, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05705453 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying SCI - Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05705453 currently recruiting?
Yes, NCT05705453 is actively recruiting participants. Contact the research team at estand@umn.edu for enrollment information.
Where is the NCT05705453 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05705453 clinical trial?
NCT05705453 is sponsored by University of Minnesota. The principal investigator is David Darrow, MD at University of Minnesota. The trial plans to enroll 50 participants.