Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

Technology
Spasticity
Online since 1 March 2024, updated 38 days ago

About this trial

This study focuses on understanding how transcutaneous spinal stimulation can help people with muscle spasms and stiffness because of a spinal cord injury. When someone has a spinal cord injury, it ca...

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T11
  • Severity (AIS)?
  • Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-T11
    Additionally, participants must
    NOT have an implanted active devices
    NOT have passive implants (plates, screws) below the level of injury

    What’s involved

    Type

    Technology

    Details

    The primary questions to be addressed are whether the intervention reduces muscle stiffness and spasms and alters spinal reflexes: Using a 100-Hz (a measure of frequency) transcutaneous spinal stimulation is better than using a 50-Hz. Transcutaneous spinal stimulation at 50 Hz differs from a single dose of baclofen. Transcutaneous spinal stimulation at 50 Hz differs from a single dose of tizanidine. Combining the 50 Hz stimulation with either baclofen or tizanidine decreases spasticity more than just taking the medicine alone. Participants will visit the Methodist Rehabilitation Center in Jackson, Mississippi, six times over a period of 3 to 5 weeks. During the first visit, the overall health and motor and sensory functions will be assessed following a spinal cord injury. For the next five visits, participants will take a study medication (tizanidine, baclofen, or a placebo). After an hour, they will receive a continuous 30-minute transcutaneous spinal stimulation at either 50 Hz, 100 Hz, or sham. The spinal reflexes and clinical assessments will be evaluated before, during, and after each intervention.

    Potential benefits

    Main benefits

    Spasticity

    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 soon
    • Trial start date
    • 1 Apr 2024
    • Organisation
    • University of Mississippi Medical Center
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Apr 2024
    • Organisation
    • University of Mississippi Medical Center

    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