NCT07210333Not yet recruiting
Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System
Source: ClinicalTrials.gov · Last updated 7 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 30 Sept 2025
- Start date
- 16 Dec 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Braincare USA Corp
- Diseases
- Stroke
- NCT number
- NCT07210333
What you commit to
- Study type: Observational
- Planned participants: 300
- From 16 Dec 2025 to the primary completion date, 31 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals with brain lesions of other etiologies, such as previous TBI and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, or illicit drug use.
Other illness
- Individuals with severe debilitating mental health disorders and/or severe debilitating neurological diseases.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitário de Lagarto Coordinator of this site? Confirm its status | Lagarto | Brazil | Unknown status |
| Hospital Universitário Getúlio Vargas Coordinator of this site? Confirm its status | Manaus | Brazil | Unknown status |
| Hospital Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.