Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study
About this trial
This trial is enrolling 20 participants (by invitation only) with chronic cervical spinal cord injury to assess safety and feasibility of Vagus Nerve Stimulation (VNS) paired with rehabilitative exercises. Participants must have previously received the ReStore Device implant as part of the SCI EFS study (NCT04288245). VNS is a technique that delivers electrical stimulation to the vagus nerve (located in the neck and extending to the abdomen) to influence neural activity. If included, participants will receive up to 36 sessions (targeting 3 sessions per week) of VNS paired with one category of rehab exercises (upper limb, lower limb, or bladder control). Final testing of safety and feasibility will be performed after 15 weeks.
Included participants
Traumatic
What’s involved
Type
Details
- Participants will receive up to 36 sessions of Vagus Nerve Stimulation (VNS) paired with rehabilitative exercises for the upper limb, or the lower limb, or bladder control. The sessions will be self-paced by participants with the aim to complete 3 sessions per week. - VNS is a technique that delivers electrical stimulation to the vagus nerve (located in the neck and extending to the abdomen) to influence neural activity. - Final testing of safety and feasibility will be performed after 15 weeks.
Potential benefits
Main benefits
General health
Additional benefits
Arm/hand function
Bladder health/function
Standing/walking/mobility
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- By invitation
- Trial start date
- 29 Aug 2024
- Organisation
- The University of Texas at Dallas
- Trial recruitment status
- By invitation
- Trial start date
- 29 Aug 2024
- Organisation
- The University of Texas at Dallas
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more