Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury

Technology
Standing/walking/mobility
Online since 18 March 2024, updated 21 days ago

About this trial

This trial is enrolling 10 individuals with spinal cord injury (>3 months) to test the effect of a “Closed-loop* Functional Spinal Cord Stimulation” on walking function. Spinal cord stimulation is a technique for stimulating the spinal cord with an implanted electrode wire placed next to the spinal cord. If included, participants will undergo surgery for implantation of the stimulation device under the skin and with the electrode wire inserted into the space surrounding the spinal cord (epidural stimulation). Standard rehabilitation will be performed before implantation for 6-10 weeks. Rehabilitation training combined with electrical stimulation will be performed for 6 months. The total duration of the study is approximately 12 months. *Closed loop stimulation typically means there is a stimulus that triggers the stimulation. It is unclear from the description what the stimulus may be in order to consider this closed loop.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 3 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T10

    What’s involved

    Type

    Technology

    Details

    - participants will undergo surgery for implantation of the stimulation device under the skin and with the electrode wire inserted into the space surrounding the spinal cord (epidural stimulation). - standard rehabilitation will be performed before implantation for 6-10 weeks. - rehabilitation training combined with electrical stimulation will be performed for 6 months. - the total duration of the study is approximately 12 months. *Closed loop stimulation typically means there is a stimulus that triggers the stimulation. It is unclear from the description what the stimulus may be in order to consider this closed loop.

    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
    • Recruiting
    • Trial start date
    • 1 Aug 2021
    • Organisation
    • Tsinghua University
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Aug 2021
    • Organisation
    • Tsinghua University

    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