Stimulation to Enhance Walking Post-SCI

Technology
Standing/walking/mobility
Online since 4 November 2021, updated 960 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries to study the effect of skin-surface electrical stimulation (transcutaneous direct current stimulation; tsDCS) on walking function. tsDCS is applied over the skin of the low back. Researchers want to see if the stimulation activates spinal cord nerves that have become dormant after injury. The stimulation is applied during locomotor training (repetitive, therapist-assisted, weight-supported walking on a treadmill). The immediate effects of stimulation will be analyzed after each of the first 2 sessions. Then, each participant will be randomly assigned to receive four training sessions per week for 4 weeks, with either a lower or higher dose of tsDCS. Participants will be unaware of the dosage level. The study will help to determine if stimulation intensity affects outcomes. Walking function will measured by standardized clinical tests for speed and endurance.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    1 year - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T12
    Additionally, participants must
    be capable of walking at least 10 feet (= 3 meters) with gait devices or help.
    NOT have pain, spasticity, skin lesions or contractures that limit walking
    NOT have implanted hardware below 8th thoracic vertebrae

    What’s involved

    Type

    Technology

    Details

    Participants will participate in the first part of the study to determine the immediate effects of 2 different stimulation doses combined with training for walking with 2 visits separated by at least 72 hours. The stimulation is delivered while walking on a treadmill for 30min supported by an overhead harness (locomotor training). Assessments will be performed before and after each visit. Participants will participate in the second part of the study to determine the effects of the intervention (stimulation plus locomotor training) when given 4 times per week over 4 weeks. Assessments will be done before and after the whole training period.

    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
    • Active
    • Trial start date
    • 1 Apr 2019
    • Organisation
    • University of Florida
    • Trial recruitment status
    • Active
    • Trial start date
    • 1 Apr 2019
    • Organisation
    • University of Florida

    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