Study on Feasibility of Stimulation on the Lumbar Part of the Spinal Cord to Improve Mobility Recovery in Patients With Sub-acute Spinal Cord Injury

Technology
Standing/walking/mobility
Online since 4 November 2021, updated 887 days ago

About this trial

This clinical trial is investigating the safety and feasibility of electrical spinal cord stimulation in individuals with early (less than 6 months) spinal cord injuries. Targeted epidural spinal stimulation (TESS) is a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord. The study will gather preliminary information on the potential for TESS to improve spinal cord function. If selected for the study, participants will undergo surgery to implant the electrodes next to the spinal cord. TESS-supported rehabilitation is included. Leg function and mobility will be measured; the effects will be investigated up to 12 months after the injury and compared to predicted recovery expectations based on standard rehabilitation.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - T11
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    3 days - 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T11
    Additionally, participants must
    be enrolled in the EMSCI study
    NOT have implanted device, e.g. pacemaker

    What’s involved

    Type

    Technology

    Details

    Surgery for the implantation of the TESS electrodes next to the spinal cord, and the neurostimulator in the abdominal region Walking and mobility outcomes over a 12 month period

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    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
    • Ended
    • Trial start date
    • 1 Feb 2022
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Feb 2022
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne

    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