Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI

Technology
Standing/walking/mobility
Online since 3 April 2022, updated 341 days ago

About this trial

This is a clinical trial to compare the effect of two forms of spinal cord stimulation on motor function in individuals with SCI. Spinal cord stimulation is a technique for modifying spinal cord function either with an implanted electrode placed next to the spinal cord or via surface electrode stimulation. If included in the study, participants will randomly be assigned to one of the two study groups: spinal cord stimulation using implanted electrodes; or short term spinal cord stimulation using electrodes on the skin surface. Final testing, including body mechanics (kinematics), bowel, bladder and sexual function, trunk stability, spasticity, and ambulation will be performed after 5 months.

Included participants

Gender
All
Age
≥ 22 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T10
    Additionally, participants must
    NOT have a history of frequent, severe, autonomic dysreflexia.
    NOT have history of frequent hypotension or frequent hypertension.
    NOT be ventilator dependent

    What’s involved

    Type

    Technology

    Details

    - Either implantation of electrodes next to the spinal cord, or attachment of electrodes to the skin surface - Stimulation during rehabilitation sessions - If electrodes were implanted, they will be removed at the end of the study

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bladder health

    Bowel health

    Sensory function

    Sexual health

    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

    • Recruitment
    • Unknown
    • Trial start date
    • 4 Mar 2022
    • Organisation
    • Mayo Clinic
    • Recruitment
    • Unknown
    • Trial start date
    • 4 Mar 2022
    • Organisation
    • Mayo Clinic

    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