Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT07210333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-30', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Differentiation of ischemic vs. hemorrhagic stroke', 'timeFrame': 'From enrollment up to 14 days in the intensive care unit.', 'description': 'Differentiation of ischemic vs. hemorrhagic stroke using brain4care non-invasive ICP waveform morphology (P2/P1 ratio, nTTP) compared to imaging and clinical reference standards.'}], 'primaryOutcomes': [{'measure': 'Diagnostic accuracy of non-invasive ICP and compliance parameters', 'timeFrame': 'From enrollment up to 14 days in the intensive care unit.', 'description': 'Diagnostic accuracy of non-invasive ICP and compliance parameters (P2/P1 ratio, nTTP) obtained with the brain4care system for detecting intracranial hypertension, assessed by sensitivity, specificity, predictive values, and ROC curve analysis, using neuroimaging and clinical evaluation as reference standards.'}], 'secondaryOutcomes': [{'measure': 'Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients', 'timeFrame': 'From enrollment up to 14 days in the intensive care unit.', 'description': 'Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients, including CT-based scales (Marshall, Rotterdam, ASPECTS, Fisher, STICH, CRASH) and neurological scales (Glasgow Coma Scale, NIHSS, Hunt-Hess, WFNS, Rankin).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Stroke', 'Traumatic Brain Injury', 'Intracranial Pressure', 'Intracranial Compliance', 'Medical Devices'], 'conditions': ['Traumatic Brain Injury (TBI) Patients', 'Stroke Hemorrhagic', 'Stroke Ischemic']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'R. d. A. P. Andrade et al., "A Nanometer Resolution Wearable Wireless Medical Device for Non Invasive Intracranial Pressure Monitoring," in IEEE Sensors Journal, vol. 21, no. 20, pp. 22270-22284, 15 Oct.15, 2021, doi: 10.1109/JSEN.2021.3090648'}, {'pmid': '12436508', 'type': 'BACKGROUND', 'citation': 'Goto Y. [Cardiac energetics and coronary circulation]. Nihon Rinsho. 1994 Jul;52 Suppl(Pt 1):67-77. No abstract available. Japanese.'}, {'pmid': '39031230', 'type': 'BACKGROUND', 'citation': 'Ocamoto GN, da Silva LN, da Silva Rocha Tomaz C, Hisatugu MT, Frigieri G, Cardim D, Goncalves RL, Russo TL, de Amorim RLO. Characterization of intracranial compliance in healthy subjects using a noninvasive method - results from a multicenter prospective observational study. J Clin Monit Comput. 2024 Dec;38(6):1249-1261. doi: 10.1007/s10877-024-01191-w. Epub 2024 Jul 20.'}]}, 'descriptionModule': {'briefSummary': "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/P1 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/neurological 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?", 'detailedDescription': 'This is a prospective, observational, multicenter, longitudinal cohort study conducted in four Brazilian states (Amazonas, São Paulo, Sergipe, and Rio Grande do Sul). The study aims to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) monitoring, using the brain4care system, for screening intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke (ischemic or hemorrhagic) admitted to multiple levels of care in the Brazilian Unified Health System (SUS), including pre-hospital care (SAMU), primary care (UBS), urgent care units (UPA), emergency rooms (PS), and intensive care units (ICUs).\n\nStudy Procedures\n\nEligible participants (≥18 years) with TBI or stroke will undergo daily non-invasive ICP and ICC monitoring using the BWS 2.0 (Braincare Wireless System). Monitoring will be performed by trained medical and nursing teams, adjusted according to care setting:\n\nSAMU (pre-hospital): 5 minutes of valid pulses during stabilization and transport.\n\nUBS, UPA, and PS: 10 minutes of valid pulses during initial evaluation; repeated daily until transfer.\n\nICU: three times daily (every 8 hours) for 10 minutes during the first 72h, then twice daily (every 12 hours) for up to 14 days, each session lasting 30 minutes.\n\nClinical data include demographics, comorbidities, neurological exam findings (Glasgow Coma Scale, Cincinnati Stroke Scale, NIHSS, Hunt-Hess, WFNS, Rankin), and vital signs. Neuroimaging will be collected when available, with application of validated CT-based scales (Marshall, Rotterdam, ASPECTS, Fisher, STICH, CRASH).\n\nTechnology\n\nThe BWS 2.0 sensor applies piezoelectric technology to detect minute cranial deformations linked to ICP waveforms, allowing calculation of morphological parameters such as P2/P1 ratio and normalized Time-to-Peak (nTTP). Changes in these parameters reflect alterations in intracranial compliance, providing a non-invasive tool to identify or exclude ICH.\n\nData Collection and Quality Assurance\n\nAll data will be recorded in REDCap, a secure, validated data capture system. A data dictionary describes all study variables, coding conventions (e.g., MedDRA for clinical events), and reference ranges. Automated range and consistency checks will be applied during data entry. Source data verification will be performed by comparing REDCap records with hospital charts, imaging reports, and device outputs.\n\nSite monitoring will ensure adherence to standard operating procedures (SOPs) for patient recruitment, informed consent, device handling, data collection, and reporting of adverse events. Periodic audits and central data review will reinforce data integrity.\n\nSample Size and Analysis\n\nAn initial sample of 300 patients was calculated to provide sufficient power for ROC curve analysis. The primary outcome is diagnostic performance (AUC, sensitivity, specificity, predictive values) of brain4care parameters against reference standards (CT and clinical scales). Secondary analyses include correlation with clinical and imaging findings, differentiation of ischemic vs. hemorrhagic stroke, and evaluation of cases with hemorrhagic transformation.\n\nStatistical methods include parametric or non-parametric tests (t-test, Mann-Whitney, ANOVA, Kruskal-Wallis), Pearson/Spearman correlations, and multivariate regression models. ROC analysis will quantify discriminatory capacity. Economic evaluation will assess cost-effectiveness, cost-benefit, and resource utilization, considering reduced need for invasive monitoring and imaging.\n\nRisk and Benefit\n\nRisks are minimal, limited to local skin irritation from sensor placement. Potential benefits include earlier recognition of ICH, reduced reliance on invasive monitoring, improved triage decisions, and optimized healthcare resource allocation in the SUS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥18 years) of both sexes presenting with clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic). Participants will be recruited from multiple levels of care within the Brazilian Unified Health System (SUS), including primary care units (UBS), urgent care units (UPA), pre-hospital emergency services (SAMU), hospital emergency rooms (PS), and intensive care units (ICUs) at participating hospitals in the states of Amazonas, São Paulo, Sergipe, and Rio Grande do Sul.', 'healthyVolunteers': False, 'eligibilityCriteria': '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/or 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/or severe debilitating neurological diseases.\n\nIndividuals who are agitated, aggressive, or uncooperative, preventing follow-up and outcome assessment.\n\nPregnant women.'}, 'identificationModule': {'nctId': 'NCT07210333', 'briefTitle': "Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System", 'organization': {'class': 'INDUSTRY', 'fullName': 'Braincare USA Corp'}, 'officialTitle': 'Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System', 'orgStudyIdInfo': {'id': 'b4cScreen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Traumatic Brain Injury', 'description': 'Traumatic Brain Injury', 'interventionNames': ['Device: non-invasive intracranial pressure monitoring']}, {'label': 'Stroke', 'description': 'Stroke', 'interventionNames': ['Device: non-invasive intracranial pressure monitoring']}], 'interventions': [{'name': 'non-invasive intracranial pressure monitoring', 'type': 'DEVICE', 'description': 'non-invasive intracranial pressure monitoring that provides continuous bedside monitoring.', 'armGroupLabels': ['Stroke', 'Traumatic Brain Injury']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69020-170', 'city': 'Manaus', 'state': 'Amazonas', 'country': 'Brazil', 'contacts': [{'name': 'Study Principal Investigator', 'role': 'CONTACT', 'email': 'amorim.robson@gmail.com', 'phone': '+ 55 (92) 9403-4101'}, {'name': 'Robson L Oliveira de Amorim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitário Getúlio Vargas', 'geoPoint': {'lat': -3.10194, 'lon': -60.025}}, {'zip': '49400-000', 'city': 'Lagarto', 'state': 'Sergipe', 'country': 'Brazil', 'contacts': [{'name': 'Study Principal Investigator', 'role': 'CONTACT', 'email': 'ritavieira@academico.ufs.br', 'phone': '+ 55 (79) 9671-0130'}, {'name': 'Rita C Almeida Vieira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitário de Lagarto', 'geoPoint': {'lat': -10.91722, 'lon': -37.65}}, {'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Study Principal Investigator', 'role': 'CONTACT', 'email': 'drfabiano.neurologia@gmail.com', 'phone': '+55 (11) 98267-7217'}, {'name': 'Fabiano Moulin de Moraes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Danilo A Cardim, PhD', 'role': 'CONTACT', 'email': 'danilo.cardim@brain4.care', 'phone': '(424) 888-2942'}, {'name': 'Gabriela Nagai Ocamoto, PhD', 'role': 'CONTACT', 'email': 'gabriela.ocamoto@brain4.care', 'phone': '+55 16 3501-4020'}], 'overallOfficials': [{'name': 'Robson L Oliveira de Amorim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Amazonas'}, {'name': 'Fabiano Moulin de Moraes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Rita C Almeida Vieira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Sergipe'}, {'name': 'Gustavo H Frigieri Vilela, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Braincare USA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to ethical and regulatory restrictions imposed by local ethics committees and data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braincare USA Corp', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Universidade Federal de Sergipe', 'class': 'OTHER'}, {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, {'name': 'Federal University of Amazonas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}