Not yet taking people in United StatesPhase 1/2

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

Key facts

Who runs it: Randy Trumbower, PT, PhD
Where: Cambridge, United StatesSee the site
Trial code: NCT05217498
Status: Not yet recruiting
Phase: Phase 1/2
People taking part: 40 people, planned
Starts: 1 Sept 2027
Expected to end: 30 Jun 2028
Type of study: Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Istradefylline
low oxygen therapy
Record updated: 20 March 2026

Who can take part

Age: 18 years to 75 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

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
ability to advance one step overground without human assistance

Who cannot take part

Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)
Undergoing concurrent physical therapy
History of seizures, brain injury, and/or epilepsy
Diabetes
Cirrhosis Caffeine and/or NSAID allergies or intolerances
Pregnant women because of the unknown effects of AIH on pregnant women and fetus

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 75 years old?

Where in United States

Spaulding Rehabilitation HospitalCambridge, United StatesContact: Randy D. Trumbower, PT, PhDNo longer taking part

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

Istradefylline+low oxygen trainingTreatment being tested
Drug: Nourianz Other Names: KW6002, Istradefylline Participants enrolled in this study arm will ingest a 20mg tablet/day containing istradefylline starting 14 days prior to the first low oxygen therapy and continuing for 14 additional days. Participants will consume a total of 28 istradefylline tablets. Other: low oxygen training Other Names: therapeutic intermittent hypoxia, acute intermittent hypoxia Participants will breathe 15 episodes/session of acute low oxygen via an automated air generator system (4 sessions/week x 2 weeks). During the 90-second episodes of low oxygen, air concentrations will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.10±0.02 (hypoxia) with 60-second room-air intervals (FIO2 0.21±0.02). Throughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.
Treatment: Istradefylline and low oxygen therapy
Placebo+low oxygen trainingExisting treatment, for comparison
This is a placebo counterpart to the istradefylline drug. Participants enrolled in this study arm will ingest a 20mg placebo tablet/day containing dextrose starting 14 days prior to the first low oxygen therapy (LOT) and continuing for 14 additional days. Participants will consume a total of 28 placebo tablets. Other: low oxygen training Other Names: therapeutic intermittent hypoxia, acute intermittent hypoxia Participants will breathe 15 episodes/session of acute low oxygen via an automated air generator system (4 sessions/week x 2 weeks). During the 90-second episodes of low oxygen, air concentrations will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.10±0.02 (hypoxia) with 60-second room-air intervals (FIO2 0.21±0.02). Throughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.
Treatment: low oxygen therapy
Istradefylline+SHAMExisting treatment, for comparison
Drug: Nourianz Other Names: KW6002, Istradefylline This is a SHAM counterpart to low oxygen therapy. Participants enrolled in this study arm will ingest a 20mg tablet/day containing istradefylline starting 14 days prior to the first SHAM therapy and continuing for 14 additional days. Participants will consume a total of 28 istradefylline tablets. Participants will breathe 15 episodes/session of SHAM via an automated air generator system (4 sessions/week x 2 weeks). The system will fill reservoir bags attached to a non-rebreathing face mask. During the 90-second episodes of SHAM, air concentrations will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.21±0.02 (normoxia) with 60-second room-air intervals (FIO2 0.21±0.02). Throughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.
Treatment: Istradefylline