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

NCT Number	NCT07210333
Lead Sponsor	Braincare USA Corp Collaborators: Universidade Federal de Sergipe, Federal University of São Paulo, Federal University of Amazonas
Conditions	Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic, Stroke Ischemic
Enrollment	300 participants
Start Date	2025-12-16
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-01-28 (estimated)
Updated on ClinicalTrials.gov	2025-10-07