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

Technology
General health
Online since 15 March 2022, updated 763 days ago

About this trial

This is a small study of 4 people to test the safety and possible therapeutic benefits of stimulating the spinal cord with 2 electrodes surgically implanted next to the spinal cord (Targeted Epidural Spinal Stimulation; TESS), on blood pressure management after spinal cord injury. If included, the participant will undergo surgery for implantation of the TESS device. Optimization of the device will be completed over one month, followed by 2 weeks of supervised at-home TESS testing over 5 sessions per week. Thereafter, the participant will have a minimum of 5 TESS sessions per week and 1 laboratory session each month, for up to 10 months.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C3 - T6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C3-T6
    Additionally, participants must
    NOT have an implanted baclofen or insulin pump
    Have orthostatic hypotension and/or autonomic dysreflexia

    What’s involved

    Type

    Technology

    Details

    • The participant will take part in 8 study phases, including screening and pre-implantation testing, • The participant will undergo surgery for implantation of the TESS device. • The device will be optimized over one month. • Supervised at-home TESS testing will be performed for 2 weeks over 5 sessions per week. • Thereafter, the participant will have a minimum of 5 TESS sessions per week and 1 laboratory session each month, for up to 10 months. • Additional testing during a configuration of additional TESS programs.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Mental health and psychosocial factors

    Sensory function

    Spasticity

    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
    • 8 Jun 2021
    • Organisation
    • Centre Hospitalier Universitaire Vaudois
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 8 Jun 2021
    • Organisation
    • Centre Hospitalier Universitaire Vaudois

    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