Not Yet RecruitingNot Applicable

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

Brazil300 participantsStarted 2025-12-16

Plain-language 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?

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria 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 Criteria 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic accuracy of non-invasive ICP and compliance parameters

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

Trial details

NCT IDNCT07210333

SponsorBraincare USA Corp

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Danilo A Cardim, PhD

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

View on ClinicalTrials.gov More Traumatic Brain Injury (TBI) Patients trials