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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRandy Trumbower, PT, PhD

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

40 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Randy Trumbower, PT, PhD

Lead sponsor

Spaulding Rehabilitation Hospital

Sponsor institution