Combining Istradefylline and Low Oxygen Therapy for Spinal Cord Injury

This study is looking at how combining a medication called istradefylline with a treatment called low oxygen therapy might help improve walking ability in people with spinal cord injuries. Low oxygen therapy involves breathing brief periods of air with less oxygen, which is thought to help the brain and spinal cord adapt. Istradefylline is a drug that may help prevent some of the potential downsides of low oxygen therapy. The study aims to see if this combination can lead to better walking speed. You may be able to join if you are between 18 and 75 years old, have a specific type of motor-incomplete spinal cord injury that happened over a year ago, and can take at least one step without help. The study will measure walking speed before and after treatments to see if they are effective. The current status of this study is unclear.

Study design
This is a randomized, placebo-controlled study planning to enroll 40 participants. Participants will be assigned to one of three groups: istradefylline plus low oxygen therapy, a placebo plus low oxygen therapy, or istradefylline plus a sham (inactive) therapy.
What's involved
You would take 20mg of istradefylline (or a placebo) daily for 28 days. For two of those weeks, you would also receive low oxygen therapy (or sham therapy) four days a week, followed by 45 minutes of walking practice.
Compensation
Not stated in the trial record.
Follow-up
Your walking speed will be measured within one day after your last treatment, and again between 7-10 days after that measurement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05217498

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

Not Yet Recruiting
PHASE1Ages 18–75InterventionalTreatment
Randy Trumbower, PT, PhD
~40 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Istradefyllinelow oxygen therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pre-Treatment Walking Speed
Measured over within 5 days of first treatment
+3 more outcomes measured
Spinal Cord Injuries
Myelopathy
1 sites across 1 states
Massachusetts1
  • Randy D Trumbower, PT, PhD · PRINCIPAL_INVESTIGATOR · Spaulding Rehabilitation Hospital

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  • Pre-Treatment Walking Speedwithin 5 days of first treatment

    Pre-Treatment Walking Speed; 10MWT (time, seconds)

  • Walking Speed Post-Treatment 1within 1 day after last treatment

    Post-Treatment Walking Speed; 10MWT (time, seconds)

  • Walking Speed Post-Treatment 2between 7-10 days after Post-Treatment 1

    Post-Treatment Walking Speed; 10MWT (time, seconds)

  • Walking Speed Post-Treatment 3between 17-20 days after Post-Treatment 1

    Post-Treatment 10MWT (time, seconds)