Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries

Technology
Standing/walking/mobility
Online since 5 November 2021, updated 837 days ago

About this trial

This is a clinical trial investigating the safety and effect of spinal cord stimulation combined with rehabilitation on individuals with chronic, incomplete spinal cord injury. The method being tested, electric epidural spinal cord stimulation (EESS), modifies spinal cord function by way of electrodes implanted on the spinal cord. Researchers want to see if the electrodes activate nerve networks in the spinal cord. The effects of stimulation will be measured mainly in terms of walking function, but also by urological and sexual function, as well as quality of life factors. If included in the trial, participants will undergo 40 days of rehabilitation with the stimulation and 40 days without the stimulation. After the first 40 days of rehabilitation, participants will rest for 30 days before completing 40 more days of rehabilitation. The order in which participants complete rehabilitation with or without the stimulation will be randomized (not in predetermined order).

Included participants

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

    Healthy volunteers
    No
    C1-T10
    Additionally, participants must
    have little or no motor deficit of the upper limbs (upper limb muscle scores ≥ 4/5)
    NOT have contraindication to MRI, e.g. implanted device such as pacemaker

    What’s involved

    Type

    Technology

    Details

    Participation in a rehabilitation program for 40 days, a break of 30 days and another rehabilitation program of 40 days The rehabilitation program consists of 2 daily sessions of 45 minutes It is not clear if surgery is required. The information provided suggests that before the first rehabilitation program begins, participants will have back surgery. During the surgery, electrodes will be placed on the spinal cord. During the rehabilitation program with stimulation, the stimulation intensity will be individually adapted. Participants will complete a series of walking, quality of life, bladder function, and sexual function tests several times. It is not clear how often these tests will be completed. Assessment of bladder function will use cystometry, which requires inserting a catheter into the bladder. It is not clear how long the study lasts.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bladder health

    General health

    Mental health

    Sexual 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
    • Recruiting
    • Trial start date
    • 12 Jul 2021
    • Organisation
    • Hopital Foch
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 12 Jul 2021
    • Organisation
    • Hopital Foch

    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