Combining Low Oxygen Therapy and an Adenosine A2a Receptor Antagonist to Improve Functional Mobility After Spinal Cord Injury

Drug
Standing/walking/mobility
Online since 28 August 2023, updated 282 days ago

About this trial

This trial is enrolling individuals with chronic incomplete spinal cord injuries to see if a drug (Istradefylline) enhances the effects of Acute Intermittent Hypoxia (AIH) training on walking function. Istradefylline is used as an adjunct drug in patients with Parkinson's disease to reduce overactivity in specific brain regions. AIH is an intervention of repeatedly breathing air with low oxygen content for brief periods, alternating with breathing room air with normal oxygen content. AIH is believed to increase spinal plasticity (strengthening nerve pathways based on new experiences), and improve walking function. If included, participants will undergo either: 1) AIH (4 sessions/week for 2 weeks) in combination with ingesting a 20mg Istradefylline tablet daily starting 14 days prior to the first AIH intervention and for 14 days after; or 2) AIH + placebo, or 3) Istradefylline + sham AIH. During the trial, blood pressure, respiratory rate, and heart rate will be monitored, as well as sleep quality and pain levels. The study will measure walking speed and distance.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C2 - T12
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 12 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C2-T12
    Additionally, participants must
    have the ability to advance one step overground without human assistance

    What’s involved

    Type

    Drug

    Details

    - Participants will undergo either 1) AIH (4 sessions/week for 2 weeks) in combination with ingesting a 20mg istradefylline tablet/day starting 14 days prior to the first AIH intervention and continuing for 14 additional days or 2) AIH + placebo, or 3) Istradefylline + sham AIH. - Throughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored as well as sleep quality and pain levels. - Final testing will be performed after 20 days.

    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 soon
    • Trial start date
    • 1 Sep 2024
    • Organisation
    • Spaulding Rehabilitation Hospital
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Sep 2024
    • 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