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

Launched by RANDY TRUMBOWER, PT, PHD · Jan 26, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help improve walking ability in people with spinal cord injuries. The researchers are studying how breathing in low levels of oxygen, combined with a medication called istradefylline, can boost the nervous system’s ability to heal and strengthen pathways that control movement. Low oxygen therapy seems to help people walk better, especially when used before practice sessions that focus on walking skills. However, the effects might be lessened by certain natural substances in the body that increase with this therapy. The goal is to see if istradefylline can help manage these substances and enhance the benefits of low oxygen therapy.

To participate in this trial, individuals need to be between 18 and 75 years old, have a specific type of spinal cord injury that hasn't changed over time, and be able to move their legs somewhat. They should also be able to take at least one step on their own. However, those with severe medical issues, pregnant women, or individuals with certain conditions like diabetes or a history of seizures cannot take part. This study aims to provide valuable insights into improving mobility for people with spinal cord injuries, and participants will receive close monitoring and support throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. age 18 and 75 years (the latter to reduce the likelihood of heart disease) medical clearance to participate
• • 2. lesion at or below C2 and above T12 with non-progressive etiology
• • 3. classified as motor-incomplete with visible volitional leg movement
• • 4. injury greater than 12 months
• • 5. 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 effects 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