Long-term Follow-up for Epidural Stimulation in SCI

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT07042815
Status
Enrolling By Invitation

Conditions

  • SCI - Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epidural Stimulation Programs — DEVICE
    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.

Study Details

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 Dates

Start date
Jan 13, 2025
Status verified
Apr 2025
Primary completion
Jul 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
91 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Home Use and Follow-Up Visit Group
    Participants will be cleared by study staff for home-use of the stimulation programs they received in the previous study. Participants will then follow and log the programs according to study staff recommendations.

Primary Outcome Measure

Motor Control Assessments with stimulation [ Time Frame: On average, 1 hour each visit completed 6 months, 1 year, and yearly ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052-

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By research site
Kessler Foundation· West Orange, NJ

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