SCI Acute Intermittent Hypoxia and Non-Invasive Spinal Stimulation Combined With Gait Training

Technology
Standing/walking/mobility
Online since 4 November 2021, updated 844 days ago

About this trial

This trial is enrolling individuals with spinal cord injuries to evaluate the effectiveness of acute intermittent hypoxia therapy (AIH) combined with transcutaneous (skin surface) spinal cord stimulation on walking and balance function. AIH is a procedure wherein the oxygen level of breathed air is reduced for a short duration (<2 min), alternated by exposure to room air with normal oxygen levels. Spinal cord stimulation is believed to activate spinal cord nerve networks. For comparison, there are three arms to the study: 1) AIH + spinal cord stimulation + gait training; 2) sham (inactive) AIH + spinal cord stimulation + gait training; and 3) sham AIH + sham spinal cord stimulation + gait training. At the end of each arm participants will cross over to another arm, and will therefore receive all three arms. The main goal is to see if AIH and spinal cord stimulation improves gait and walking function, posture and balance, and cardiovascular conditioning.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C3 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    No
    C3-S5
    Additionally, participants must
    must not be currently receiving regular physical therapy services.
    must not have epilepsy or a concussion within 6 months.
    NOT have implanted device, e.g. pacemaker or drug pump

    What’s involved

    Type

    Technology

    Details

    Participation in the conventional regular walking training with or without tSCS. Follow-up assessments up to 12 months.

    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
    • Recruiting
    • Trial start date
    • 1 Dec 2020
    • Organisation
    • Shirley Ryan AbilityLab
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Dec 2020
    • Organisation
    • Shirley Ryan AbilityLab

    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