Status:
NOT_YET_RECRUITING
Combining Low Oxygen Therapy and an Adenosine A2a Receptor Antagonist to Improve Functional Mobility After Spinal Cord Injury
Lead Sponsor:
Randy Trumbower, PT, PhD
Conditions:
Spinal Cord Injuries
Myelopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 improv...
Detailed Description
This randomized, placebo-controlled clinical trial will examine the efficacy of a selective adenosine 2a antagonist (istradefylline) to enhance the beneficial effects of LOT-related gains on overgroun...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05217498
Start Date
September 1 2027
End Date
June 30 2028
Last Update
October 31 2025
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States, 02138