Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury

Technology
Bladder health
Online since 5 November 2021, updated 886 days ago

About this trial

This trial is recruiting individuals with chronic paraplegia to test the effect of spinal cord stimulation on standing, stepping, and bladder function. Participants will undergo surgery to implant an electrode array next to the spinal cord (epidural stimulation - scES). Participants will receive either 160 sessions of standing and stepping training (suspended on treadmill) sessions with scES; or 80 sessions of bladder training (capacity and voiding) followed by 80 sessions of standing and stepping training with scES. Both groups will train for 1-1.5 hours, 5 days per week. Independent walking function will be assessed; the investigators also hope to optimize stimulator programming and wireless communication platforms to improve the patient experience.

Included participants

Gender
All
Age
18 - 65 years
Injury level
T1 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T1-T10
    Additionally, participants must
    NOT be able to stand or step independently
    NOT be able to move joints of legs
    NOT be dependent on ventilator

    What’s involved

    Type

    Technology

    Details

    The participant will receive either: 160 standing and stepping training sessions with epidural stimulation or 80 sessions of bladder training (capacity and voiding) followed by 80 sessions of standing and stepping training with epidural stimulation. Both groups will train for 1-1.5 hours, 5 days per week. Final testing will be performed after the completion of the intervention.

    Potential benefits

    Main benefits

    Bladder health

    Additional benefits

    General 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
    • 4 Apr 2022
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 4 Apr 2022
    • 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