Restoring Hemodynamic Stability Using Targeted Epidural Spinal Stimulation Following Spinal Cord Injury

Surgery
Standing/walking/mobility
Online since 26 January 2022, updated 760 days ago

About this trial

This trial is enrolling 4 individuals with chronic cervical (neck area) or high thoracic (chest area) spinal cord injuries to test the effect of an implanted electrical stimulation device (Targeted Epidural Spinal Stimulation - TESS) on blood pressure stability. The research team wants to see if spinal cord stimulation can reduce the incidence and severity of orthostatic hypotension (low blood pressure) and autonomic dysreflexia (sudden high blood pressure). If included, the participant will be assessed before and after the device is implanted. After a month to customize the device to the individual, two weeks of supervised at-home use with additional scheduled laboratory TESS and assessment sessions for 25 weeks. The study will measure the long-term safety and effect of spinal cord stimulation on cardiovascular health, respiratory function, and quality of life.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C3 - T6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C3-T6
    Additionally, participants must
    • NOT have an implanted pacemaker and/or defibrillator.
    NOT have a history of myocardial infarction or cerebrovascular event

    What’s involved

    Type

    Surgery

    Details

    • The participant will undergo daily supervised at-home TESS sessions for 2 weeks. • Thereafter, and up to 25 weeks, participants will conduct supported at-home sessions as well as regular laboratory visits during a long-term at-home hemodynamic TESS phase. • Several clinical evaluations are planned to evaluate participants' hemodynamic and neurological status, cardiovascular functional status, respiratory function, trunk stability, and quality of life. • Final testing will be performed after 9 months.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Mental 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 Dec 2021
    • Organisation
    • University of Calgary
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 1 Dec 2021
    • 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