Spinal Cord Stimulation and Autonomic Response in People With SCI.

Technology
General health
Online since 8 November 2021, updated 834 days ago

About this trial

This is a trial to test the effect of stimulating the spinal cord, either with an implanted electrode placed next to the spinal cord (epidural spinal cord stimulation: eSCS) or via surface stimulation (transcutaneous spinal cord stimulation: tSCS), on blood pressure when the participant sits upright from lying down (orthostatic hypotension) and bladder, bowel, and sexual function. Individuals with a spinal cord injury who have previously been implanted with an epidural stimulator will be invited to participate in 2 visits (one screening visit to determine eligibility and one eSCS + measurement visit). If participants with SCI who do not have an epidural stimulator are included, they will participate in either 4 study visits (1 screening visit and 3 times 1-hour tSCS + measurement visits) or 21 study visits (1 screening visit, 5 times 1-hour tSCS + measurement, and 15 tSCS only visits). All measurements will be done in a lying and an upright position.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C1 - T6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    No
    C1-T6
    Additionally, participants must
    have a spinal cord injury for at least 1 year and at least 6 months from any spinal surgery.
    have a neurological injury between C1- T6.
    have one of the following ASIA impairment scale (AIS):

    What’s involved

    Type

    Technology

    Details

    Individuals who have previously been implanted with an epidural stimulator will be invited to participate in 2 visits, comprising one screening visit to determine eligibility and one eSCS + measurement visit. Individuals who do not have an epidural stimulator will participate in either 4 study visits (1 screening visit and 3 times 1-hour tSCS + measurement visits) or 21 study visits (1 screening visit, 5 times 1-hour TSCS + measurement, and 15 tSCS only visits). All measurements will be done in a lying and an upright position.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Bladder health

    Bowel health

    Mental health

    Sexual 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
    • Unknown
    • Trial start date
    • 1 Feb 2020
    • Organisation
    • University of Calgary
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Feb 2020
    • Organisation
    • University of Calgary

    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