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

NCT07210333 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-10-07

No results posted yet for this study

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

Interventions

DEVICE

non-invasive intracranial pressure monitoring

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

Sponsors & Collaborators

  • Universidade Federal de Sergipe

    collaborator OTHER

  • Federal University of São Paulo

    collaborator OTHER

  • Federal University of Amazonas

    collaborator OTHER

  • Braincare USA Corp

    lead INDUSTRY

Principal Investigators

  • Robson L Oliveira de Amorim, PhD · Federal University of Amazonas

  • Fabiano Moulin de Moraes, PhD · Federal University of São Paulo

  • Rita C Almeida Vieira, PhD · Federal University of Sergipe

  • Gustavo H Frigieri Vilela, PhD · Braincare USA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2027-12-31
Completion
2028-01-28
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07210333 on ClinicalTrials.gov