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Long-term Follow-up for Epidural Stimulation in SCI

NCT07042815 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-06-29

No results posted yet for this study

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.

Conditions

  • SCI - Spinal Cord Injury

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Kessler Foundation

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2028-07-31
Completion
2028-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07042815 on ClinicalTrials.gov