Combination Therapy to Improve SCI Recovery.

Rehabilitation
Standing/walking/mobility
Online since 22 December 2022, updated 22 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries to test the effect of combining low oxygen (acute intermittent hypoxia - AIH) before skin-surface (transcutaneous) spinal cord stimulation, and walking training on walking function. If included, participants will be randomly assigned to one of three groups: one will receive 8 sessions of AIH before walking training with transcutaneous spinal stimulation; one group will get 8 sessions of sham AIH (normal air) before walking training with transcutaneous spinal stimulation; the third group will get 8 sessions of AIH before walking training, and sham spinal stimulation. Final testing for walking strength and function will be performed after 12 weeks. Testing will also include surveys regarding bowel and bladder function and spasticity.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C2 - L2
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 12 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C2-L2
    Additionally, participants must
    NOT have active implanted devices.
    be ambulatory.

    What’s involved

    Type

    Rehabilitation

    Details

    If included, participants will be randomly assigned to an experimental or two Sham groups and receive either 8 sessions over 2 weeks of: 1) 15 episodes of acute intermittent hypoxia before 45 minutes of gait training with transcutaneous spinal stimulation (80% of involuntary motor threshold) or 2) 15 episodes of room air before 45 minutes of gait training with transcutaneous spinal stimulation (80% of involuntary motor threshold) or 3) 15 episodes of acute intermittent hypoxia before 45 minutes of gait training with sham transcutaneous spinal stimulation. Final testing will be performed after 12 weeks.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Pain

    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

    • Recruitment
    • Unknown
    • Trial start date
    • 1 Oct 2022
    • Organisation
    • Spaulding Rehabilitation Hospital
    • Recruitment
    • Unknown
    • Trial start date
    • 1 Oct 2022
    • Organisation
    • Spaulding Rehabilitation Hospital

    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