[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455971":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":44,"locations":54,"responsibleParty":67,"collaborators":49,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":49,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":49,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":99,"whyStopped":49,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Spaulding Rehabilitation Hospital","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Istradefylline+low oxygen training","EXPERIMENTAL","Drug: Nourianz Other Names: KW6002, Istradefylline\n\nParticipants enrolled in this study arm will ingest a 20mg tablet\u002Fday 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.\n\nOther: low oxygen training Other Names: therapeutic intermittent hypoxia, acute intermittent hypoxia\n\nParticipants will breathe 15 episodes\u002Fsession of acute low oxygen via an automated air generator system (4 sessions\u002Fweek 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).\n\nThroughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.",[13,14],"Drug: Istradefylline","Device: low oxygen therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo+low oxygen training","ACTIVE_COMPARATOR","This is a placebo counterpart to the istradefylline drug.\n\nParticipants enrolled in this study arm will ingest a 20mg placebo tablet\u002Fday 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.\n\nOther: low oxygen training Other Names: therapeutic intermittent hypoxia, acute intermittent hypoxia\n\nParticipants will breathe 15 episodes\u002Fsession of acute low oxygen via an automated air generator system (4 sessions\u002Fweek 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).\n\nThroughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.",[14],{"label":21,"type":17,"description":22,"interventionNames":23},"Istradefylline+SHAM","Drug: Nourianz Other Names: KW6002, Istradefylline\n\nThis is a SHAM counterpart to low oxygen therapy.\n\nParticipants enrolled in this study arm will ingest a 20mg tablet\u002Fday 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.\n\nParticipants will breathe 15 episodes\u002Fsession of SHAM via an automated air generator system (4 sessions\u002Fweek 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).\n\nThroughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.",[13],[25,33],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Istradefylline","Consume 20mg tablet of istradefylline for 28 consecutive days.",[21,9],[31,32],"KW6002","Nourianz",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DEVICE","low oxygen therapy","Breath intermittent low oxygen 4 days\u002Fweek 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.",[9,16],[39],"acute intermittent hypoxia",[41],{"name":42,"affiliation":5,"role":43},"Randy D Trumbower, PT, PhD","PRINCIPAL_INVESTIGATOR",[45,51],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Randy D. Trumbower, PT, PhD","CONTACT","6179526953",null,"randy.trumbower@mgh.harvard.edu",{"name":52,"role":47,"phone":48,"phoneExt":49,"email":53},"William Muter","wmuter@partners.org",[55],{"facility":5,"status":49,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":49},"Cambridge","Massachusetts","02138","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-71.10561,42.3751,{"lat":65,"lon":64},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"SPONSOR_INVESTIGATOR","Randy Trumbower, PT, PhD","Assistant Professor","100455971","phase-1-combining-low-oxygen-therapy-and-an-adenosine-a2a-receptor-antagonist-to-improve-functional-mobility-after-spinal-cord-injury-100455971",false,"NCT05217498","Combining Low Oxygen Therapy and an Adenosine A2a Receptor Antagonist to Improve Functional Mobility After Spinal Cord Injury","A Selective Adenosine 2a Antagonist to Enhance Training-related Gains in Walking Function for Persons With Chronic, Incomplete Spinal Cord Injury","Inclusion Criteria:\n\n1. age 18 and 75 years (the latter to reduce the likelihood of heart disease) medical clearance to participate\n2. lesion at or below C2 and above T12 with non-progressive etiology\n3. classified as motor-incomplete with visible volitional leg movement\n4. injury greater than 12 months\n5. ability to advance one step overground without human assistance\n\nExclusion Criteria:\n\n1. Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)\n2. Pregnant women because of the unknown effects of AIH on pregnant women and fetus\n3. History of seizures, brain injury, and\u002For epilepsy\n4. Undergoing concurrent physical therapy\n5. Diabetes\n6. Cirrhosis Caffeine and\u002For NSAID allergies or intolerances","ALL","18 Years","75 Years",{"count":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","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.",[90,91],"Spinal Cord Injuries","Myelopathy",[93,94,95,96,97,98],"spinal cord injury","walking","motor control","istradefylline","adenosine","strength","NOT_YET_RECRUITING","2026-03-18",{"date":102,"type":103},"2026-03-20","ACTUAL",{"date":105,"type":83},"2027-09-01",{"date":107,"type":83},"2028-06-30",{"name":69,"class":6},1]