Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study

Technology
General health
Online since 15 March 2025, updated 85 days ago

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

Gender
All
Age
18 - 64 years
Injury level
C1 - C8
  • Severity (AIS)?
  • Time since injury
    ≥ 12 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    have completed phase 2 of the SCI EFS study (NCT04288245)

    What’s involved

    Type

    Technology

    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

    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