Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Drug
Arm/hand function
Online since 31 May 2022, updated 635 days ago

About this trial

This is a clinical trial enrolling individuals with chronic incomplete cervical (neck area) spinal cord injuries to measure the effect of daily acute intermittent hypoxia therapy (dAIH) to improve upper-and lower extremity function. Intermittent hypoxia delivers brief exposures of low oxygen air alternating with normal room air. Recent studies have shown that this technique can strengthen nerve pathways related to motor function after SCI, thus improving walking, breathing, grip strength, and limb strength. This study utilizes the Rapael Glove, an exoskeleton for the hand, comparing its effect to general physical therapy and training for hand and arm function. The oxygen air content is controlled through a respiratory face mask, and will either be normal room air or low (9-10%) oxygen air. Participants will not be informed about the oxygen content of the air they are breathing. The study has 5 experimental arms to compare active treatments versus sham (inactive) treatments: dAIH + Rapael Glove; dAIH + upper and lower extremity training by staff; room air + Rapael Glove; room air + training by staff; or room air without training. Note: two treatment arms include sham dAIH (room air); one arm does not include any training. Training sessions will last about 30-45 minutes.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C3 - T1
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    6 months - 70 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    Yes
    C3-T1
    Additionally, participants must
    be right handed
    NOT take drugs acting on central nervous system

    What’s involved

    Type

    Drug

    Details

    Participation in a series of sessions determined by the treatment group assignment lasting 30-45 minutes each. Participation in outcome measurement examinations over the course of 12 weeks.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    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
    • Recruiting
    • Trial start date
    • 9 Apr 2020
    • Organisation
    • Shirley Ryan AbilityLab
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 9 Apr 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