Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
NCT ID: NCT07210333
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2025-12-16
2028-01-28
Brief Summary
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The main questions it aims to answer are:
Can 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?
Can this approach differentiate ischemic stroke from hemorrhagic stroke with sufficient accuracy?
Does the use of brain4care contribute to earlier detection, improved clinical decision-making, and cost reduction in emergency settings?
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Detailed Description
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Study Procedures
Eligible 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:
SAMU (pre-hospital): 5 minutes of valid pulses during stabilization and transport.
UBS, UPA, and PS: 10 minutes of valid pulses during initial evaluation; repeated daily until transfer.
ICU: 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.
Clinical 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).
Technology
The 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.
Data Collection and Quality Assurance
All 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.
Site 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.
Sample Size and Analysis
An 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.
Statistical 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.
Risk and Benefit
Risks 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Traumatic Brain Injury
Traumatic Brain Injury
non-invasive intracranial pressure monitoring
non-invasive intracranial pressure monitoring that provides continuous bedside monitoring.
Stroke
Stroke
non-invasive intracranial pressure monitoring
non-invasive intracranial pressure monitoring that provides continuous bedside monitoring.
Interventions
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non-invasive intracranial pressure monitoring
non-invasive intracranial pressure monitoring that provides continuous bedside monitoring.
Eligibility Criteria
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Inclusion Criteria
Age ≥ 18 years.
Clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic).
Signed 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.
Exclusion Criteria
Individuals with scalp or skin lacerations that prevent proper placement of the brain4care sensor.
Individuals with craniectomy or skull fractures.
Individuals with severe debilitating mental health disorders and/or severe debilitating neurological diseases.
Individuals who are agitated, aggressive, or uncooperative, preventing follow-up and outcome assessment.
Pregnant women.
18 Years
ALL
No
Sponsors
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Universidade Federal de Sergipe
OTHER
Federal University of São Paulo
OTHER
Federal University of Amazonas
OTHER
Braincare USA Corp
INDUSTRY
Responsible Party
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Principal Investigators
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Robson L Oliveira de Amorim, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Amazonas
Fabiano Moulin de Moraes, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Rita C Almeida Vieira, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Sergipe
Gustavo H Frigieri Vilela, PhD
Role: STUDY_CHAIR
Braincare USA
Locations
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Hospital Universitário Getúlio Vargas
Manaus, Amazonas, Brazil
Hospital Universitário de Lagarto
Lagarto, Sergipe, Brazil
Hospital São Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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
Goto Y. [Cardiac energetics and coronary circulation]. Nihon Rinsho. 1994 Jul;52 Suppl(Pt 1):67-77. No abstract available. Japanese.
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.
Other Identifiers
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b4cScreen
Identifier Type: -
Identifier Source: org_study_id
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