Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait

Technology
Standing/walking/mobility
Online since 3 November 2021, updated 888 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries to test the effect of deep brain stimulation (DBS) to improve walking. The stimulation will target an area of the brain that coordinates muscle patterns for limb movements that are then activated in the spinal cord. Previous studies showed that electrical stimulation of this area (called the mesencephalic locomotor; MLR) induces locomotion. If selected, participants will undergo surgery to place the DBS electrode in the MLR. If electrode placement is successful, it will be connected to a device that will generate electrical pulses (Medtronic Activa SC Impulse Generator). If placement is unsuccessful, the electrode will be removed. Participants with the complete implanted DBS system (electrode plus impulse generator) will be discharged from the hospital 14 days after surgery. Post-surgery rehabilitation will be include training with a FLOAT device (Free Levitation for Overground Active Training). Walking function will be assessed on day 14 after surgery and again at months 1, 3, 6 and 12.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-T10

    What’s involved

    Type

    Technology

    Details

    2 assessment sessions before enrollment. DBS surgery. Post-surgery rehabilitation including training on the FLOAT. Assessments for 12 months.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    Bladder health

    General health

    Pain

    Sexual health

    Spasticity

    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
    • 15 Mar 2018
    • Organisation
    • University of Zurich
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Mar 2018
    • Organisation
    • University of Zurich

    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