Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System

NCT07210333 | Not Yet Recruiting FDA Device

• 1 other identifier: b4cScreen
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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). 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?

Conditions

Traumatic Brain Injury (TBI) Patients; Stroke Hemorrhagic; Stroke Ischemic

Keywords

Stroke; Traumatic Brain Injury; Intracranial Pressure; Intracranial Compliance; Medical Devices

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of non-invasive ICP and compliance parameters

  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.

  From enrollment up to 14 days in the intensive care unit.

Secondary Outcomes (1)

• Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients

  From enrollment up to 14 days in the intensive care unit.

Other Outcomes (1)

• Differentiation of ischemic vs. hemorrhagic stroke

  From enrollment up to 14 days in the intensive care unit.

Study Arms (2)

Traumatic Brain Injury

Traumatic Brain Injury

Device: non-invasive intracranial pressure monitoring

Stroke

Stroke

Device: non-invasive intracranial pressure monitoring

Interventions

non-invasive intracranial pressure monitoring DEVICE

non-invasive intracranial pressure monitoring that provides continuous bedside monitoring.

Stroke; Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients of both sexes.
• 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.

You may not qualify if:

• Individuals with brain lesions of other etiologies, such as previous TBI and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, or illicit drug use.
• 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.

Sponsors & Collaborators

• Braincare USA Corp: lead
• Universidade Federal de Sergipe: collaborator
• Federal University of São Paulo: collaborator
• Federal University of Amazonas: collaborator

Study Sites (3)

Hospital Universitário Getúlio Vargas

Manaus, Amazonas, 69020-170, Brazil

Location

Hospital Universitário de Lagarto

Lagarto, Sergipe, 49400-000, Brazil

Location

Hospital São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (3)

• 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

  BACKGROUND

• Goto Y. [Cardiac energetics and coronary circulation]. Nihon Rinsho. 1994 Jul;52 Suppl(Pt 1):67-77. No abstract available. Japanese.

  PMID: 12436508 BACKGROUND

• 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.

  PMID: 39031230 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hemorrhagic Stroke; Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robson L Oliveira de Amorim, PhD

  Federal University of Amazonas

  PRINCIPAL INVESTIGATOR

• Fabiano Moulin de Moraes, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Rita C Almeida Vieira, PhD

  Federal University of Sergipe

  PRINCIPAL INVESTIGATOR

• Gustavo H Frigieri Vilela, PhD

  Braincare USA

  STUDY CHAIR

Central Study Contacts

Danilo A Cardim, PhD

CONTACT

(424) 888-2942; danilo.cardim@brain4.care

Gabriela Nagai Ocamoto, PhD

CONTACT

+55 16 3501-4020; gabriela.ocamoto@brain4.care

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 28, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)