Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury

Technology
General health
Online since 6 November 2021, updated 924 days ago

About this trial

This trial is enrolling individuals with chronic spinal cord injuries to test the effect of combining two spinal cord stimulation methods on movement and other bodily functions. One technique, epidural stimulation, activates spinal cord nerve networks using implanted electrodes placed next to the spinal cord. The other method, dorsal root stimulation, uses a similar approach to activate spinal nerve roots close to the spinal cord. Electrodes are implanted using a needle inserted through the skin and are removed when the study is completed. The study will explore whether this combined stimulation modifies spinal cord function related to movement. If selected, participants will undergo surgery for the implantation of the electrodes, and then will receive 10 rehabilitative sessions. Researchers will measure nerve function (electrophysiology) and movement, including overground walking. The study includes questionnaires for participants to assess changes in bowel, bladder, sexual function, and spasticity. Final testing will occur after about 4 weeks.

Included participants

Gender
All
Age
≥ 22 years
Injury level
C7 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C7-T10
    Additionally, participants must
    NOT have a body mass > 113 kg (250 pounds)
    NOT have a history of cardiopulmonary disorder
    NOT have a history of seizures

    What’s involved

    Type

    Technology

    Details

    Surgery for the implantation of the electrodes next to the spinal cord 10 rehabilitative session Electrophysiological ad biomechanical testing Surgery to remove the electrodes

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Bladder health/function

    Sensory function

    Sexual health

    Spasticity

    Standing/walking/mobility

    Mechanism of action

    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
    • 24 Sep 2021
    • Organisation
    • Mayo Clinic
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 24 Sep 2021
    • Organisation
    • Mayo Clinic

    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