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.
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
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
Crossover
Istradefylline
DrugConsume 20mg tablet of istradefylline for 28 consecutive days.
low oxygen therapy
DeviceBreath intermittent low oxygen 4 days/week over 2 consecutive weeks. Intermittent low oxygen consists of 15, 90-second episodes of breathing low oxygen at 10% oxygen with 60-second intervals at 21% oxygen.
Pre-Treatment Walking Speed
Pre-Treatment Walking Speed; 10MWT (time, seconds)
Walking Speed Post-Treatment 1
Post-Treatment Walking Speed; 10MWT (time, seconds)
Walking Speed Post-Treatment 2
Post-Treatment Walking Speed; 10MWT (time, seconds)
Walking Speed Post-Treatment 3
Post-Treatment 10MWT (time, seconds)
Pre-Treatment Walking Distance
Pre-Treatment 6MWT (distance, meters)
Walking Distance Post-Treatment 1
Post-Treatment 6MWT (distance, meters)
Walking Distance Post-Treatment 2
Post-Treatment 6MWT (distance, meters)
Walking Distance Post-Treatment 3
Post-Treatment 6MWT (distance, meters)
Click on the lead sponsor to view all of their trials.
Randy Trumbower, PT, PhD
Lead sponsor
Spaulding Rehabilitation Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
