Improving Bowel Function and Quality of Life After Spinal Cord Injury

Technology
Bowel health
Online since 4 November 2021, updated 895 days ago

About this trial

This study is enrolling individuals with chronic spinal cord injuries to measure the effect of spinal cord stimulation (SCS) on bowel function. SCS is a technique for activating spinal cord nerve networks. If selected for the study, participants will undergo surgery (electrodes implanted next to the spinal cord - epidural) and receive follow-up assessments for up to 24 months. Participants in this trial are enrolled in another trial testing the effect of SCS on blood pressure control and trunk muscle function. Each will be randomly assigned to one of two intervention groups: stimulation for either blood pressure or trunk control, with or without training for standing. The research team wants to see if the stimulation method for blood pressure or trunk control also affects bowel function. The bowel study will measure changes in bowel function and overall quality of life

Included participants

Gender
All
Age
18 - 75 years
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    2 years - 75 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-T12
    Additionally, participants must
    NOT have implanted device, e.g. pacemaker
    NOT be dependent on ventilator

    What’s involved

    Type

    Technology

    Details

    Surgery for the implantation of the SCS electrodes. Receiving two sets of training interventions, each one lasting 80 sessions for a total of 160 sessions. Interventions and follow-ups for up to 24 months.

    Potential benefits

    Main benefits

    Bowel health

    Additional benefits

    Arm/hand function

    Bladder health/function

    General health

    Mental health and psychosocial factors

    Standing/walking/mobility

    Mechanism of action

    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 Sep 2018
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Sep 2018
    • 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