Task-specific Epidural Stimulation Study

Technology
General health
Online since 8 November 2021, updated 883 days ago

About this trial

This trial is recruiting individuals with chronic spinal cord injuries to test whether spinal cord stimulation improves recovery of blood pressure regulation, voluntary movement, and standing. Participants will have an electrical device (16-electrode epidural array) surgically implanted into the lower back over the spinal cord. Epidural spinal cord stimulation will be combined with a standing device (stand training). Participants will be randomly assigned to one of four groups: epidural stimulation for voluntary leg movement; epidural stimulation for voluntary leg movement combined with stand training; epidural stimulation for cardiovascular function; or epidural stimulation for cardiovascular function with stand training. The main goals are to measure the effect of the stimulation on cardiovascular (blood pressure) and voluntary motor function, and to compare leg movement training only with leg movement training plus stand training. Assessments will also include respiratory, bladder, bowel and sexual function. Quality of life and potential health care costs also will be assessed.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 2 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have ability to move legs or stand on own

    What’s involved

    Type

    Technology

    Details

    Surgery to implant the device into the lower back. The participant will receive 1) scES for voluntary leg movement, 2) scES for voluntary leg movement combined with stand training, 3) scES for cardiovascular function, or 4) scES for cardiovascular function combined with stand training. Testing sessions over 1.5 years. Training specifications are not provided. Further information needs to be acquired directly from the investigator.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Bladder health

    Bowel health

    Mental health

    Sexual health

    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
    • Recruiting
    • Trial start date
    • 8 Nov 2017
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 8 Nov 2017
    • Organisation
    • University of Louisville

    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