Clinical Trial

Long-term Follow-up for Epidural Stimulation in SCI

Enrolling by Invitation
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Summary
The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury. The main aims are to: 1. provide support for those with epidural stimulators who choose to continue stimulating because they deemed them to improve their quality of life 2. provide additional sites for follow-up so that the financial burden can be minimized for the research participants to travel 3. collect long-term safety data; and 4. when feasible collect data to understand the sustainability of outcomes. Participants will: * receive stimulation programs and software for the activities and/or functions completed in the previous study and demonstrate to the research staff that I can conduct them without their help to use at home * continue using the stimulation programs at home as directed by the research staff * return to Kessler Foundation for a follow-up visit (approx. 2 hours) with assessments at 6 months, 1 year, and once a year after enrolled in the follow-up study last until either the device is turned off, removed or the device is commercially approved.
Trial Details
NCT Number NCT07042815
Lead Sponsor Kessler Foundation
Conditions SCI - Spinal Cord Injury
Enrollment 91 participants
Start Date 2025-01-13
Primary Completion 2028-07 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2025-06-29