rTMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury

Rehabilitation
Standing/walking/mobility
Online since 3 November 2021, updated 839 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries to test a type of brain stimulation combined with treadmill stepping (locomotor) training. The stimulation method, transcranial magnetic stimulation (TMS), is a non-invasive technique which uses a magnetic field to stimulate the motor cortex region of the brain. A coil held over the head delivers a magnetic stimulus that activates the brain and spinal cord. The locomotor training will utilize a body weight-support treadmill (Biodex) system. The percentage of body weight support and speed of the treadmill will be modified based on the performance of each participant. Participants will be randomly assigned to one of the two experimental groups; one receiving the repetitive TMS pulses, the other receiving a sham TMS protocol that resembles the TMS delivery but without having a therapeutic effect. In total, 12 therapeutic sessions will be performed over the course of a month. Three sessions will be done each week, 20 min for each. Behavioral and neurological assessments will be measured before, during, and at the end of the study. A final follow-up assessment will be conducted 30-days after the intervention.

Included participants

Gender
All
Age
18 - 55 years
Injury level
T3 - S1
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    8 months - 55 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    T3-S1
    Additionally, participants must
    NOT be a community walker (someone who can independently walk more than 100 meters)
    NOT have other implanted device, e.g. pacemaker
    NOT have metallic implants in the head

    What’s involved

    Type

    Rehabilitation

    Details

    12 therapeutic sessions will be performed over the time course of a month. Three sessions will be done each week, 20 min duration for each training session. Locomotor training while receiving repetitive TMS or sham-TMS pulses at the head. Non-invasive assessment sessions before, after 6 sessions, after 12 sessions and 1 month after the intervention.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General health

    Mental health

    Sensory function

    Spasticity

    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
    • Unknown
    • Trial start date
    • 30 Jan 2018
    • Organisation
    • Universidade Federal de Pernambuco
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 30 Jan 2018
    • Organisation
    • Universidade Federal de Pernambuco

    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