Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)

Technology
Pain
Online since 11 November 2021, updated 831 days ago

About this trial

This is a trial to test the safety and effectiveness of spinal cord stimulation on pain and muscle function after spinal cord injury. If included, participants will undergo surgery for implantation of a stimulation device next to the spinal cord (epidural). Participants will then receive 9 months of conventional medical and rehabilitation management with either: 1) spinal cord stimulation turned on; or 2) spinal cord stimulation turned off (no stimulation). Participants will not know which group they are in until the end of the 9 months. At the end of the 9 months, participants who were in the spinal cord stimulation off group (no stimulation) can have their spinal cord stimulator turned on.

Included participants

Gender
All
Age
22 - 65 years
Injury level
T1 - T12
  • Severity (AIS)?
  • AIS-A
    Time since injury
    1 year - 5 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T1-T12
    Additionally, participants must
    have chronic pain (i.e., pain for more than 3 months, on more than 50% of the days)
    be able to undergo MRI (no implanted metallic devices)

    What’s involved

    Type

    Technology

    Details

    Participants will undergo surgery for implantation of the stimulation device next to the spinal cord. Participants will receive 9 months of conventional medical and rehabilitation management with either: 1) spinal cord stimulation turned on; or 2) spinal cord stimulation turned off (no stimulation). At the of the 9 months, the sham group will also be able to turn on SCS. Final testing will be performed after 9 months.

    Potential benefits

    Main benefits

    Pain

    Additional benefits

    Arm/hand function

    Bladder health

    General health

    Mental health

    Sensory function

    Spasticity

    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
    • 30 Dec 2021
    • Organisation
    • Duke University
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 30 Dec 2021
    • Organisation
    • Duke 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