About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Istradefylline
- low oxygen therapy
Treatment groups
Sponsors and collaborators
Randy Trumbower, PT, PhD
Lead sponsor
Spaulding Rehabilitation Hospital
Sponsor institution