[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482520":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":44,"centralContacts":49,"locations":57,"responsibleParty":97,"collaborators":99,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":31,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":60,"whyStopped":31,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Spaulding Rehabilitation Hospital","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"AIH + Walking Training with transcutaneous spinal stimulation (WALKtSTIM)","EXPERIMENTAL","Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.",[13,14],"Other: Daily acute intermittent hypoxia","Other: Walking + tSTIM",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham + WALKtSTIM","SHAM_COMPARATOR","Sham acute intermittent hypoxia will be used as a pretreatment before walking training paired with transcutaneous spinal cord stimulation.",[20,14],"Other: Room air (SHAM)",{"label":22,"type":17,"description":23,"interventionNames":24},"AIH + Walking Training with sham transcutaneous spinal stimulation (WALKtSHAM)","Acute Intermittent Hypoxia will be used as a pretreatment before walking training paired with sham transcutaneous spinal cord stimulation.",[13,25],"Other: Walking + Sham transcutaneous spinal stimulation (tSHAM)",[27,32,36,40],{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Daily acute intermittent hypoxia","Each participant will be exposed to 8 sessions of daily acute intermittent hypoxia via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02).",[22,9],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Room air (SHAM)","Each participant will be exposed to 8 sessions of daily room air via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 minute normoxia (FIO2=0.21±0.02).",[16],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Walking + tSTIM","Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.",[9,16],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Walking + Sham transcutaneous spinal stimulation (tSHAM)","Individuals will participate in 45 minutes of gait training while having SHAM transcutaneous spinal cord stimulation. The stimulation will briefly increase to 80% involuntary motor threshold and then brought down to 0 within 30 seconds.",[22],[45],{"name":46,"affiliation":47,"role":48},"Randy Trumbower, PT, PhD","Harvard Medical School (HMS and HSDM)","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":31,"email":54},"Noah Piazza, BS","CONTACT","617-952-6953","npiazza2@mgb.org",{"name":46,"role":52,"phone":31,"phoneExt":31,"email":56},"randy.trumbower@mgh.harvard.edu",[58,83],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Shirley Ryan AbilityLab","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-87.65005,41.85003,{"lat":70,"lon":69},[73,77,81],{"name":74,"role":52,"phone":75,"phoneExt":31,"email":76},"Shreya Aalla, BS","312-238-7323","saalla@sralab.org",{"name":78,"role":52,"phone":79,"phoneExt":31,"email":80},"Sara Prokup, PT, DPT","312-238-1355","sprokup@ricres.org",{"name":82,"role":48,"phone":31,"phoneExt":31,"email":31},"Arun Jayaraman, PT, PhD",{"facility":5,"status":60,"city":84,"state":85,"zip":86,"country":64,"countryCode":65,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Cambridge","Massachusetts","02138",{"type":67,"coordinates":88},[89,90],-71.10561,42.3751,{"lat":90,"lon":89},[93,96],{"name":94,"role":52,"phone":95,"phoneExt":31,"email":54},"Noah C Piazza, BS","6179526822",{"name":46,"role":48,"phone":31,"phoneExt":31,"email":31},{"type":48,"investigatorFullName":46,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Principal Investigator",[100,103],{"name":101,"class":102},"United States Department of Defense","FED",{"name":59,"class":6},"100482520","combination-therapy-to-improve-sci-recovery-100482520",false,"NCT05563103","Combination Therapy to Improve SCI Recovery.","Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery in Persons With Chronic SCI: The BO2ST Trial","BO2ST","Inclusion Criteria:\n\n* 18 to 70 years of age\n* medically stable with medical clearance from study physician to participate\n* SCI at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level\n* non-progressive etiology of spinal injury\n* American Spinal Injury Association (ASIA) scores of C-D at initial screen\n* ambulatory (able to complete the 10-meter walk test without support from another person)\n* chronic injury (define as \\> 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery\n\nExclusion Criteria:\n\n* severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the lower extremities, severe systemic inflammation\n* \\\u003C 24 on Mini-Mental Exam\n* severe recurrent autonomic dysreflexia\n* history of severe cardiovascular\u002Fpulmonary complications including hypertension (systolic blood pressure \\> 150 mmHg)\n* pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded)\n* botulinum toxin injections in lower extremity muscles within the prior three months\n* history of tendon or nerve transfer surgery in the lower extremity\n* untreated severe sleep-disordered breathing characterized by uncontrolled hypoxia and sleep fractionation that may impact the outcome of this study.\n* active implanted devices (e.g., intrathecal baclofen pump)\n* receiving concurrent electrical stimulation\n* motor threshold evoked by transcutaneous spinal stimulation \\>200 mA","ALL","18 Years","70 Years",{"count":116,"type":117},60,"ESTIMATED","INTERVENTIONAL",[120],"NA","The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury.",[123],"Spinal Cord Injuries",[125,126,127,128,129,130,131,132],"Walk","Rehabilitation","Strength","Movement","Spinal cord injury","low oxygen","electrical stimulation","walking training","2026-03-18",{"date":135,"type":136},"2026-03-20","ACTUAL",{"date":138,"type":136},"2023-01-17",{"date":140,"type":117},"2026-12",{"name":5,"class":6},2]