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

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Spinal Cord Injuries, Myelopathy

In brief

Breathing brief, moderate bouts of low oxygen trigger (low oxygen therapy, LOT) spinal plasticity (the ability of the nervous system to strengthen neural pathways based on new experiences), and improve walking after spinal cord injury (SCI). The greatest improvements in walking ability occur when LOT is administered prior to skill-based walking practice (WALK). However, the enduring benefits of LOT on walking recovery may be undermined by the accumulation of LOT-induced increase in extracellular adenosine. The goal of the study is to understand the extent to which istradefylline (adenosine 2a receptor antagonist) may limit the competing mechanisms of adenosine on LOT-induced walking recovery following SCI.

Key facts

Study ID

NCT05217498

Run by

Randy Trumbower, PT, PhD

People needed

40

Starts

2027-09-01

Expected to finish

2028-06-30

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age 18 and 75 years (the latter to reduce the likelihood of heart disease) medical clearance to participate
• lesion at or below C2 and above T12 with non-progressive etiology
• classified as motor-incomplete with visible volitional leg movement
• injury greater than 12 months
• ability to advance one step overground without human assistance

You may not qualify if…

• Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)
• Pregnant women because of the unknown effects of AIH on pregnant women and fetus
• History of seizures, brain injury, and/or epilepsy
• Undergoing concurrent physical therapy
• Diabetes
• Cirrhosis Caffeine and/or NSAID allergies or intolerances

Where it is running

• Spaulding Rehabilitation Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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