Non-Invasive Triage for Intracranial Hypertension in Prehospital Care

NCT07747636 | Not Yet Recruiting FDA Device

• 1 other identifier: 89168125.1.0000.0040
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with a sudden brain injury, such as stroke or head trauma, before they reach the hospital. The tools are a wearable sensor called Brain4care, placed on the head, and an ultrasound measurement of the eye's optic nerve. Neither tool requires needles, incisions, or any invasive procedure. The study has two parts. In the first part, researchers will use both tools on patients treated by the Mobile Emergency Care Service (SAMU) in Salvador, Brazil, to check how accurately the tools can detect high pressure inside the skull. The results from these tools will not be used to guide the patient's care during this part of the study. In the second part, some patients will be assessed using these tools as part of their emergency care, while other patients will receive standard emergency care. Researchers will compare how often each group of patients is correctly sent to a hospital with the specialized brain surgery services they may need. The goal of this research is to help emergency teams identify patients with dangerous brain pressure earlier and get them to the right hospital faster, which may improve their chances of recovery.

Conditions

Acute Brain Injury; Stroke; Traumatic Brain Injury; Subarachnoid Hemorrhage; Intracranial Hypertension

Keywords

Non-invasive intracranial pressure monitoring; Brain4care; Optic nerve sheath diameter; Prehospital triage; Emergency medical services; Neurocritical care; Intracranial pressure waveform

Outcome Measures

Primary Outcomes (1)

• Proportion of patients correctly referred to a hospital with neurosurgical capability

  Proportion of patients appropriately directed to a hospital with neurosurgical support, based on imaging findings and/or the need for neurosurgical intervention, compared between the intervention (B4C/ONSD-assisted triage) and control (standard prehospital care) groups. This outcome assesses whether non-invasive triage reduces both under-referral (patients needing neurosurgery sent to centers without this capability) and over-referral (unnecessary burden on specialized centers).

  From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival

Secondary Outcomes (6)

• Time from first medical contact to definitive neurosurgical intervention

  From first prehospital contact until neurosurgical intervention, up to 30 days

• 30-day mortality

  30 days after the acute brain injury event

• Functional outcome at 90 days (modified Rankin Scale)

  90 days after the acute brain injury event

• Length of hospital stay

  From hospital admission to discharge, assessed up to 180 days

• Adverse events related to use of the B4C device and ONSD ultrasound

  From prehospital assessment until hospital admission, assessed up to 24 hours

Study Arms (2)

Standard Prehospital Care

NO INTERVENTION

Participants receive standard prehospital assessment and care according to current SAMU protocols. Clinical and neurological evaluation and the decision to refer the patient to a hospital (with or without neurosurgical capability) are based on standard clinical and operational criteria, without use of the Brain4care device or optic nerve sheath diameter ultrasound.

B4C/ONSD-Assisted Triage

EXPERIMENTAL

In addition to standard prehospital assessment, participants are evaluated using the Brain4care (B4C) non-invasive intracranial pressure monitor and ultrasound measurement of optic nerve sheath diameter (ONSD). The decision to prioritize transport to a hospital with neurosurgical capability takes into account the results of these non-invasive assessments alongside standard clinical criteria.

Device: Brain4care non-invasive intracranial pressure monitor; Diagnostic Test: Optic nerve sheath diameter ultrasound

Interventions

Brain4care non-invasive intracranial pressure monitor DEVICE

A wearable, non-invasive sensor (FDA 510(k) cleared, K240821) placed on the scalp that detects micrometric skull deformations associated with fluctuations in intracranial pressure. The device analyzes the pulse waveform morphology to estimate intracranial compliance and infer changes in intracranial pressure, without requiring any invasive procedure. Application time is estimated at up to 5 minutes.

B4C/ONSD-Assisted Triage

Optic nerve sheath diameter ultrasound DIAGNOSTIC_TEST

A point-of-care ultrasound measurement of the diameter of the optic nerve sheath, which correlates with intracranial pressure. Although it does not provide an absolute measurement of intracranial pressure, an enlarged optic nerve sheath diameter is a recognized bedside indicator of intracranial hypertension.

B4C/ONSD-Assisted Triage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Attended by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil
• Clinical presentation suggestive of acute stroke (sudden focal neurological deficit or sudden and severe headache) OR moderate/severe traumatic brain injury (Glasgow Coma Scale)

You may not qualify if:

• Individuals with brain injuries of other etiologies, such as prior traumatic brain injury (TBI) and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, and illicit drug use;
• Individuals with scalp and/or skin lacerations that prevent positioning of the brain4care sensor;
• Individuals with craniectomy;
• Severe debilitating mental health disorders and/or severe debilitating neurological diseases;
• Agitated, aggressive, or uncooperative individuals whose condition prevents follow-up and outcome assessment;
• Pregnant women.

Sponsors & Collaborators

• Juliana Caldas: lead

MeSH Terms

Conditions

Intracranial Hypertension; Brain Injuries; Stroke; Brain Injuries, Traumatic; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Davi J Fontoura Solla, PhD

CONTACT

+55 71 9978-1989; davisolla@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Phase 2 is open-label. In Phase 1, outcomes assessors interpreting reference-standard neuroimaging or invasive intracranial pressure monitoring were blinded to the B4C and ONSD results.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct Professor

Model Details: This study has two sequential phases. Phase 1 is a single-group observational proof-of-concept study (n=60) assessing the diagnostic accuracy of the B4C and ONSD methods, with no influence on clinical care. Phase 2 is a parallel-group randomized controlled trial (n=120) comparing standard prehospital care to B4C/ONSD-assisted triage.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07