STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury.

Technology
Standing/walking/mobility
Online since 25 September 2021, updated 973 days ago

About this trial

This trial is recruiting individuals with chronic incomplete spinal cord injuries to test using an implanted electrical stimulation device in combination with overground robot assisted rehabilitation training. The main goal is to test if the stimulation (closed-loop Epidural Electrical Stimulation -EES) with walking training (body weight support system - BWSS) is safe and can improve walking. The study lasts about 8-12 months for each participant. Each will be evaluated before the EES is implanted, train with BWSS while optimizing EES for a period of 5-6 months, with the option to continue training with a home-use system for up to 3 years.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    12 months - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T10
    Additionally, participants must
    have had an injury for at least 12 months and completed an in-patient rehabilitation program.
    Have neurological level of injury between C1 and T10.
    ASIA impairment scale (AIS) is one of the following:

    What’s involved

    Type

    Technology

    Details

    6-8 weeks before EES implantation surgery: 6 days of tests (5 in Lausanne and 1 in Zurich), followed by 3 weeks of BWSS training. EES implantation surgery and EES customization over 6-8 weeks when the participant will need to be present at CHUV University Hospital in Lausanne for 4-5 days per week. BWSS training with EES, 4 days per week for 5 months at CHUV University Hospital in Lausanne. The final tests will last 5 days (4 in Lausanne and 1 in Zurich). After the study, there will be an option to continue with a home-use system for up to 3 years.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General 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
    • Active
    • Trial start date
    • 1 Jul 2016
    • Organisation
    • Centre Hospitalier Universitaire Vaudois
    • Trial recruitment status
    • Active
    • Trial start date
    • 1 Jul 2016
    • 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