RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation

Technology
General health
Online since 2 May 2023, updated 415 days ago

About this trial

This trial is enrolling 3 individuals with chronic motor complete spinal cord injuries between T1 and L1 to test the feasibility of epidural spinal cord stimulation (SCS) in combination with robotic-assisted rehabilitation. Epidural SCS is a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord to modify spinal cord function. If included, participants will undergo a 4-week rehabilitation session before device implantation. One month after surgery, participants will undergo 24 weeks of rehabilitation. Final safety assessments will be performed after 2 years.

Included participants

Gender
All
Age
≥ 21 years
Injury level
T2 - L1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    T2-L1
    Additionally, participants must
    Have preservation of some muscle reflexes below the level of injury
    NOT have significant autonomic dysreflexia or orthostatic hypotension

    What’s involved

    Type

    Technology

    Details

    - 4-week rehabilitation session before implanting the device. - Surgery for implanting the device next to the spinal cord. - One month after surgery, participants will undergo 24 weeks of rehabilitation. - Final safety assessments will be performed after 2 years.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    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
    • 19 Dec 2022
    • Organisation
    • National Neuroscience Institute
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 19 Dec 2022
    • Organisation
    • National Neuroscience Institute

    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