Combining Low Oxygen Therapy and an Adenosine A2a Receptor Antagonist to Improve Functional Mobil… (NCT05217498) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Combining Low Oxygen Therapy and an Adenosine A2a Receptor Antagonist to Improve Functional Mobility After Spinal Cord Injury
United States40 participantsStarted 2027-09-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
Pre-Treatment Walking Speed
Timeframe: within 5 days of first treatment
2
Walking Speed Post-Treatment 1
Timeframe: within 1 day after last treatment
3
Walking Speed Post-Treatment 2
Timeframe: between 7-10 days after Post-Treatment 1
4
Walking Speed Post-Treatment 3
Timeframe: between 17-20 days after Post-Treatment 1