[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609113":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":37,"locations":47,"responsibleParty":96,"collaborators":98,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":10,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":10,"enrollmentInfo":113,"targetDuration":116,"studyType":117,"phases":10,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":127,"whyStopped":10,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Braincare USA Corp","INDUSTRY",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Traumatic Brain Injury",null,[12],"Device: non-invasive intracranial pressure monitoring",{"label":14,"type":10,"description":14,"interventionNames":15},"Stroke",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"DEVICE","non-invasive intracranial pressure monitoring","non-invasive intracranial pressure monitoring that provides continuous bedside monitoring.",[14,9],[23,27,30,33],{"name":24,"affiliation":25,"role":26},"Robson L Oliveira de Amorim, PhD","Federal University of Amazonas","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Fabiano Moulin de Moraes, PhD","Federal University of São Paulo",{"name":31,"affiliation":32,"role":26},"Rita C Almeida Vieira, PhD","Federal University of Sergipe",{"name":34,"affiliation":35,"role":36},"Gustavo H Frigieri Vilela, PhD","Braincare USA","STUDY_CHAIR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Danilo A Cardim, PhD","CONTACT","(424) 888-2942","danilo.cardim@brain4.care",{"name":44,"role":40,"phone":45,"phoneExt":10,"email":46},"Gabriela Nagai Ocamoto, PhD","+55 16 3501-4020","gabriela.ocamoto@brain4.care",[48,67,82],{"facility":49,"status":10,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hospital Universitário Getúlio Vargas","Manaus","Amazonas","69020-170","Brazil","BR",{"type":56,"coordinates":57},"Point",[58,59],-60.025,-3.10194,{"lat":59,"lon":58},[62,66],{"name":63,"role":40,"phone":64,"phoneExt":10,"email":65},"Study Principal Investigator","+ 55 (92) 9403-4101","amorim.robson@gmail.com",{"name":24,"role":26,"phone":10,"phoneExt":10,"email":10},{"facility":68,"status":10,"city":69,"state":70,"zip":71,"country":53,"countryCode":54,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hospital Universitário de Lagarto","Lagarto","Sergipe","49400-000",{"type":56,"coordinates":73},[74,75],-37.65,-10.91722,{"lat":75,"lon":74},[78,81],{"name":63,"role":40,"phone":79,"phoneExt":10,"email":80},"+ 55 (79) 9671-0130","ritavieira@academico.ufs.br",{"name":31,"role":26,"phone":10,"phoneExt":10,"email":10},{"facility":83,"status":10,"city":84,"state":84,"zip":85,"country":53,"countryCode":54,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Hospital São Paulo","São Paulo","04024-002",{"type":56,"coordinates":87},[88,89],-46.63611,-23.5475,{"lat":89,"lon":88},[92,95],{"name":63,"role":40,"phone":93,"phoneExt":10,"email":94},"+55 (11) 98267-7217","drfabiano.neurologia@gmail.com",{"name":28,"role":26,"phone":10,"phoneExt":10,"email":10},{"type":97,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[99,102,103],{"name":100,"class":101},"Universidade Federal de Sergipe","OTHER",{"name":29,"class":101},{"name":25,"class":101},"100609113","non-invasive-intracranial-pressure-monitoring-to-improve-emergency-care-in-brazils-public-health-system-100609113",false,"NCT07210333","Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System","Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System","Inclusion Criteria\n\nPatients of both sexes.\n\nAge ≥ 18 years.\n\nClinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic).\n\nSigned informed consent form by the patient or by a legally authorized representative in cases where the patient is unable to consent due to the severity of the clinical condition. If the legal representative is not present at the time of admission or initial care, consent may be obtained retrospectively.\n\nExclusion Criteria\n\nIndividuals with brain lesions of other etiologies, such as previous TBI and\u002For stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, or illicit drug use.\n\nIndividuals with scalp or skin lacerations that prevent proper placement of the brain4care sensor.\n\nIndividuals with craniectomy or skull fractures.\n\nIndividuals with severe debilitating mental health disorders and\u002For severe debilitating neurological diseases.\n\nIndividuals who are agitated, aggressive, or uncooperative, preventing follow-up and outcome assessment.\n\nPregnant women.","ALL","18 Years",{"count":114,"type":115},300,"ESTIMATED","14 Days","OBSERVATIONAL","The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2\u002FP1 ratio and nTTP) obtained with the brain4care system for the screening of intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke treated in Brazil's public health system (SUS).\n\nThe main questions it aims to answer are:\n\nCan non-invasive ICP and ICC pulse morphology reliably identify or exclude intracranial hypertension, cerebral edema, and hemorrhage compared to CT findings and clinical\u002Fneurological evaluations?\n\nCan this approach differentiate ischemic stroke from hemorrhagic stroke with sufficient accuracy?\n\nDoes the use of brain4care contribute to earlier detection, improved clinical decision-making, and cost reduction in emergency settings?",[120,121,122],"Traumatic Brain Injury (TBI) Patients","Stroke Hemorrhagic","Stroke Ischemic",[14,9,124,125,126],"Intracranial Pressure","Intracranial Compliance","Medical Devices","NOT_YET_RECRUITING","2025-09-30",{"date":130,"type":131},"2025-10-07","ACTUAL",{"date":133,"type":115},"2025-12-16",{"date":135,"type":115},"2028-01-28",{"name":5,"class":6},3]