Kessler Foundation
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.
SCI participants who previously had an epidural stimulation device and completed the initial study can continue using stimulation programs at home once they have proven to study staff that they can use the programs and device on their own. This follow-up study will give insight into potential benefits from long-term use of spinal stimulation. In-person follow-up visits (approx. 2 hours long) will be requested at 6-months, 1 year, and once a year until the device is removed or approved for commercial use. If the participant can't come to Kessler for an in-person visit, a remote tele-health vis…
Inclusion Criteria: * at least 18 years of age * have a spinal cord injury that is not getting worse * received a neurostimulator and electrode array as part of a previous study * choose to continue epidural stimulation in the home and community * have completed a previous IRB approved epidural stimulation study at a participating research site Exclusion Criteria: * heart, lung, bladder, kidney or other untreated medical disorder unrelated to SCI * choose not to use the epidural stimulation as recommended by the investigators * withdrawn from the main epidural stimulation study or made the…
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.
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