[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503776":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":29,"interventions":40,"overallOfficials":20,"centralContacts":48,"locations":54,"responsibleParty":97,"collaborators":100,"id":103,"slug":20,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":20,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":20,"overallStatus":57,"whyStopped":20,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"James J. Peters Veterans Affairs Medical Center","FED",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Systolic blood pressure","determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo","3 years",[14,17],{"measure":15,"description":16,"timeFrame":12},"Cerebral blood flow velocity","determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo",{"measure":18,"description":19,"timeFrame":12},"Symptoms of autonomic dysreflexia and orthostatic hypotension","determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"SINGLE",[28],"PARTICIPANT",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Study 1","EXPERIMENTAL","Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension.",[35],"Drug: Midodrine Hydrochloride",{"label":37,"type":32,"description":38,"interventionNames":39},"Study 2","Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort.",[35],[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Midodrine Hydrochloride","Determine best drug and dose to increase and stabilize SBP during orthostatic tilt",[31,37],[47],"Droxidopa",[49],{"name":50,"role":51,"phone":52,"phoneExt":20,"email":53},"Matt G. Maher, MS","CONTACT","9733243588","matt.maher@va.gov",[55,74],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Kessler Foundation","RECRUITING","West Orange","New Jersey","07052","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-74.23904,40.79871,{"lat":67,"lon":66},[70],{"name":71,"role":51,"phone":72,"phoneExt":20,"email":73},"Matthew T Maher, MS","201-566-0291","MMaher@Kesslerfoundation.org",{"facility":75,"status":57,"city":76,"state":77,"zip":78,"country":61,"countryCode":62,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"James J Peters VA Medical Center","The Bronx","New York","10468",{"type":64,"coordinates":80},[81,82],-73.86641,40.84985,{"lat":82,"lon":81},[85,90,94],{"name":86,"role":51,"phone":87,"phoneExt":88,"email":89},"Finn E Fox, BS","718-584-9000","5418","fiona.fox2@va.gov",{"name":91,"role":51,"phone":87,"phoneExt":92,"email":93},"Jorge Chavez, BS","5420","jorge.chavez1@va.gov",{"name":95,"role":96,"phone":20,"phoneExt":20,"email":20},"Jill M Wecht, EdD","PRINCIPAL_INVESTIGATOR",{"type":96,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Jill M. Wecht, Ed.D.","Research Scientist",[101],{"name":56,"class":102},"OTHER","100503776",false,"NCT05839652","Treatment of Orthostatic Hypotension in SCI","Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury","SCI","Inclusion Criteria:\n\n* traumatic spinal cord injury\n* at least 12 months post injury\n* injury level of C1-T6\n* AIS A, B or C\n* non-ambulatory\n* non-ventilator\n\nExclusion Criteria:\n\n* Active psychiatric disorder\n* Stroke or cerebrovascular disease\n* Alzheimer's Disease or dementia\n* Unmanaged cardiac arrhythmias\n* Concurrent systemic, hepatic, or renal disease\n* Suspected or diagnosed malignancy\n* Neurological disease other than SCI\n* Self-reported history of three or more symptomatic episodes of AD per day","ALL","18 Years","60 Years",{"count":114,"type":115},25,"ESTIMATED","INTERVENTIONAL",[118],"PHASE4","The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.",[121],"Hypotension","2024-09-27",{"date":124,"type":125},"2024-10-01","ACTUAL",{"date":127,"type":125},"2023-07-01",{"date":129,"type":115},"2026-06-30",{"name":5,"class":6},2]