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

• Status: Not yet recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Breathing brief, moderate bouts of low oxygen (acute intermittent hypoxia, AIH) trigger spinal plasticity and improve walking function after spinal cord injury (SCI). However, extracellular adenosine accumulates during hypoxia exposures and may undermine the efficacy of AIH training-induced walking recovery. The goal of the study is to understand how caffeine may augment the effects of AIH training on walking recovery and spinal plasticity (the ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Randy Trumbower, PT, PhD
• Treatments: Istradefylline

Criteria

Inclusion Criteria:

1. age 18 and 75 years (the latter to reduce likelihood of heart disease) medical clearance to participate

2. lesion at or below C2 and above L5 with non-progressive etiology

3. classified as motor-incomplete with visible volitional leg movement injury greater than 6 months

4. ability to advance one step overground without human assistance

Exclusion Criteria:

1. Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)

2. Pregnant women because of the unknown affects of AIH on pregnant women and fetus

3. History of seizures, brain injury, and/or epilepsy

4. Undergoing concurrent physical therapy

5. Diabetes

6. Cirrhosis Caffeine and/or NSAID allergies or intolerances