Autonomic Effects of Stimulation in SCI

Technology
General health
Online since 19 April 2023, updated 307 days ago

About this trial

This trial is enrolling individuals with chronic spinal cord injury at the levels C3-T1 to test the effect of skin-surface (transcutaneous) spinal cord stimulation (TSCS) to increase blood pressure, increase exercise endurance and heart rate recovery. TSCS is a technique for stimulating the spinal cord via surface electrodes to modify spinal cord function. If included, participants will make 7 visits of 3-4 hours in duration, separated by no less than 3 days. Visits 1-3 will be screening assessments and will determine stimulation parameters. In visits 4-5, electrode placement will be optimized for participants to perform arm exercises with TSCS in one visit and without stimulation in the other visit. Visits 6 and 7 will assess core temperature when in a cool environment, both with the stimulator on and off. Final testing will be performed after 2 years.

Included participants

Gender
All
Age
35 - 50 years
Injury level
C3 - T1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C3-T1
    Additionally, participants must
    NOT be ventilator dependent.

    What’s involved

    Type

    Technology

    Details

    - Total of 7 visits, 3-4 hours in duration, separated by no less than 3 days. - Visits 1-3 will consist of screening assessments and determination of stimulation parameters. - In visits 4-5, participants will perform arm exercises with TSCS in one visit and without stimulation in the other visit. - Visits 6 and 7 will consist of assessing core temperature when in a cool environment with the stimulator on and off. - Final testing will be performed after 2 years.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    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
    • 24 Jul 2023
    • Organisation
    • VA Office of Research and Development
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 24 Jul 2023
    • Organisation
    • VA Office of Research and Development

    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