Long-term Follow-up for Epidural Stimulation in SCI
Enrolling by invitation · Not applicable
Conditions studied: SCI - Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT07042815
- Run by
- Kessler Foundation
- People needed
- 91
- Starts
- 2025-01-13
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2025-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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- withdrawn from the main epidural stimulation study or made the choice to remove the stimulator/return the controller to the site
- new surgeries, diagnoses, or other changes in status since completion of main epidural study that may affect the ability to complete assessments
- Unable to undergo an MRI
- Conditions that may make me ineligible for transcranial magnetic stimulation (a kind of brain stimulation through the skin)
Where it is running
- Kessler Foundation — West Orange, New Jersey, United States
Full record on ClinicalTrials.gov
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