Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait After Spinal Cord Injury (SCI) (NCT07689227) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait After Spinal Cord Injury (SCI)
United States20 participantsStarted 2026-09-30
Plain-language summary
The purpose of this study is to evaluate the safety, feasibility, and preliminary effectiveness of the ReWire system, which delivers vagus nerve stimulation (VNS) paired with lower limb rehabilitation to improve gait in individuals with mobility impairments resulting from chronic, incomplete spinal cord injury (SCI).
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to provide signed and dated informed consent.
. Willingness and ability to comply with all study procedures and protocol requirements for the duration of the study.
. Age 18 to 64 years.
. Chronic, non-penetrating, motor incomplete spinal cord injury \[Association Impairment Scale (AIS) grade C or D\] occurring ≥12 months prior to enrollment, resulting in impairment in lower limb function.
. Ambulatory with residual gait impairment attributable to spinal cord injury.
. Self-selected gait speed of \< 0.8 m/s as measured by the 10 meter walk test.
. Score of 2 or less on at least 4 measures on the Ambulation subsection of the SCI-Functional Independence scale (SCI-FIS).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ReWire System Safety
Timeframe: From device implantation to up to 2 years following implantation.
2
ReWire System Feasibility
Timeframe: All visits after implantation, up to approximately 26 weeks post-enrollment.
. In otherwise good general health as determined by medical history and physical examination.
Exclusion criteria
. Any history of spinal cord injuries by penetrating traumatic, non-traumatic or congenital causes.
. Evidence of right-sided recurrent laryngeal nerve injury on pre-operative laryngoscopy, if required (Note: Participants with a history of right-sided anterior cervical surgery must undergo laryngoscopy prior to surgical scheduling. A finding of right-sided recurrent laryngeal nerve injury results in exclusion).
. Excessive scar tissue on intraoperative assessment that precludes safe implantation (Note: Participants with a history of left-sided anterior cervical surgery will undergo intraoperative assessment of scar tissue. If excessive scar tissue is deemed to preclude safe implantation, the procedure will be abandoned and the participant excluded for safety reasons. A history of left-sided anterior cervical surgery or prior recurrent laryngeal nerve injury alone does not result in exclusion).