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Long-term Follow-up for Epidural Stimulation in SCI
Sponsor: Kessler Foundation
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.
Official title: Multi Site Long-term Follow-up for Those With Experimental Epidural Stimulation After Severe Spinal Cord Injury
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
91
Start Date
2025-01-13
Completion Date
2028-08
Last Updated
2025-06-29
Healthy Volunteers
No
Conditions
Interventions
Epidural Stimulation Programs
Epidural stimulations will accompany stimulation programs that have been established during research visits in the prior study and have been recommended by the clinical research team for use in the home and community. Stimulation programs will be given for activities (such as standing or walking) and/or responses that were completed in the previous study. This will be continued until the device is removed or approved for commercial use.
Locations (1)
Kessler Foundation
West Orange, New Jersey, United States