AMPLIFY Study: Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotor Rehabilitation After SCI

Technology
Standing/walking/mobility
Online since 23 August 2023, updated 287 days ago

About this trial

This trial is enrolling up to 18 individuals with chronic incomplete spinal cord injuries, at or above T12, to test the effect of skin-surface (transcutaneous) spinal direct current stimulation (tsDCS) in combination with locomotor training (LT) on walking function. tsDCS is a non-invasive electrical stimulation of the spinal cord delivered by surface electrodes on the skin of the lower back. If included, participants will undergo 20 sessions ( 4 sessions/week for 5 weeks) of either: 1) 30 minutes continuous ("high dose") tDCS + LT; or 2) 30 seconds ("low dose") tDCS + LT. Walking assessments will be performed before and after the intervention period. Final testing will be performed 2 weeks after the intervention.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C1-T12
    Additionally, participants must
    be able to walk 3 meters with or without devices, braces, or assistance of one person
    NOT have diagnosis of other neurologic condition

    What’s involved

    Type

    Technology

    Details

    - participants will undergo 20 sessions (30min/session, 5 weeks x 4 sessions/week) of either 1) active tDCS + LT or 2) sham tDCS + LT. - Walking assessments will be performed before and after the intervention period. - Final testing will be performed 2 weeks after the intervention.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    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
    • 10 Mar 2023
    • Organisation
    • University of Florida
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 10 Mar 2023
    • 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