Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury

Rehabilitation
General health
Online since 8 November 2021, updated 891 days ago

About this trial

This is a trial to test the usability of a brain imaging technique (functional magnetic resonance imaging; fMRI) to detect brain activity changes during an intervention and to predict intervention-related recovery after chronic thoracic spinal cord injury. fMRI measures brain activity by detecting blood flow changes. If included in this trial, the participant will either undergo 1) an active cycling program with functional electrical stimulation (FES), a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles, or 2) a passive cycling program without FES (control group will have an externally powered cycle). The sessions will include 3, 1 hour sessions per week, for 4 weeks. Neurological examinations (ISNCSCI exam) and fMRI scans will be done at weeks 0, 2, and 4.

Included participants

Gender
All
Age
18 - 65 years
Injury level
T1 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T1-T12
    Additionally, participants must
    have a spinal cord injury for at least 6 months.
    have a neurological level of injury between T1-T12.
    have one of the following ASIA impairment scale (AIS):

    What’s involved

    Type

    Rehabilitation

    Details

    1 hour sessions, 3 times per week, for 4 weeks of 1) an active cycling program with FES or 2) a passive cycling program without FES (control group). Neurological examinations and fMRI scans at weeks 0, 2, and 4.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Sensory function

    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
    • Ended
    • Trial start date
    • 1 Aug 2019
    • Organisation
    • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    • Trial recruitment status
    • Ended
    • Trial start date
    • 1 Aug 2019
    • Organisation
    • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    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