Non-invasive Pressure Monitoring for Brain Emergencies in Brazil
Tests a non-invasive device measuring brain pressure in adults with head injury or stroke.
Plain-language title generated from the registry record
Registry title: Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
Key facts
- Where
- Lagarto, Manaus, and São Paulo, BrazilSee the 3 sites
Where in Brazil
- Hospital Universitário de LagartoLagarto, BrazilNo longer taking part
- Hospital Universitário Getúlio VargasManaus, BrazilNo longer taking part
- Hospital Sao PauloSão Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Braincare USA Corp
- Trial code
- NCT07210333
- Record updated
- 7 October 2025
- Original description
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).Read full original descriptionShow less
Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System
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?
Inclusion: 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.
Exclusion: 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 severe debilitating mental health disorders and/or severe debilitating neurological diseases; Individuals with scalp or skin lacerations that prevent proper placement of the brain4care sensor; Individuals with craniectomy or skull fractures; Individuals who are agitated, aggressive, or uncooperative, preventing follow-up and outcome assessment; Pregnant women.