Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries

Technology
Arm/hand function
Online since 5 November 2021, updated 894 days ago

About this trial

This is a clinical study enrolling individuals with chronic incomplete cervical (neck area) spinal cord injuries to assess the safety and effect of an electrical stimulation device on arm and hand function. The technique, called targeted plasticity therapy (TPT), uses brief pulses of stimulation of the vagus nerve paired with specific rehabilitation exercises. Researchers want to see if this combination activates preserved spinal cord nerve networks (plasticity). If selected for the trial, participants will be randomly assigned to one of two study groups: 1) the experimental group (vagus nerve stimulation with upper extremity rehabilitation); or the control group (sham or placebo vagus nerve stimulation with upper extremity rehabilitation). Sham stimulation is an inactive intervention with no therapeutic effect. Participants are not aware if they are getting active stimulation or sham. Each group will receive rehabilitation and stimulation for 18 in-office sessions over the course of approximately 6 weeks. Changes in arm and hand function will be measured. All participants have the option to receive 18 more sessions of rehabilitation with active vagus nerve stimulation.

Included participants

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

    Healthy volunteers
    No
    C1-C8

    What’s involved

    Type

    Technology

    Details

    18 stimulation sessions over the time course of 6 weeks Upper limb rehabilitation If the participant desires, an additional 18 visits (over 6 more weeks) may be done

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    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
    • 15 Feb 2021
    • Organisation
    • Baylor Research Institute
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Feb 2021
    • Organisation
    • Baylor Research Institute

    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