Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury

Technology
Arm/hand function
Online since 16 August 2023, updated 35 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries at the cervical level to test the safety and feasibility of pairing vagus nerve stimulation (VNS) with rehabilitation. VNS is a technique that applies electrical stimulation through an implanted device near the collarbone with wires connected to the vagus nerve on the side of the neck. Investigators want to see if VNS improves upper limb motor recovery. If included, participants will undergo surgery for implantation of the device. Then, participants will receive 18 goal-directed, 1.5-2 hour, arm rehabilitation therapy sessions in combination with either 1) active VNS, or 2) sham VNS over a period of 6 weeks. This will be followed by a 90-day home exercise program. Final safety assessments and testing of arm function will be performed at the end of the home exercise program.

Included participants

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

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    NOT have prior history of vagus nerve injury

    What’s involved

    Type

    Technology

    Details

    - Surgery for implantation of the device - 18 goal-directed, 1.5-2 hour, arm rehabilitation therapy sessions in combination with either 1) active VNS or 2) sham VNS over a period of 6 weeks. - This will be followed by 90 days home exercise program. - Final safety assessments and testing of arm function will be performed at the end of the 90 home exercise program.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Mental health

    Pain

    Spasticity

    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
    • Recruiting
    • Trial start date
    • 1 Jul 2023
    • Organisation
    • The University of Texas Health Science Center, Houston
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jul 2023
    • Organisation
    • The University of Texas Health Science Center, Houston

    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