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Can a head sensor and eye ultrasound spot brain pressure in the ambulance?

NCT ID NCT07747636

Diagnosis Sponsor: Juliana Caldas Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with sudden brain injury, such as stroke or head trauma, before they reach the hospital. The tools are a wearable sensor placed on the head and an ultrasound measurement of the eye's optic nerve, both avoiding needles or incisions. The study will compare how accurately these tools identify patients needing specialized brain surgery, potentially improving triage and outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Brain4care non-invasive intracranial pressure monitor and optic nerve sheath diameter ultrasound
What this could lead to
If effective, this could help emergency teams identify patients with dangerous brain pressure earlier and get them to the right hospital faster, potentially improving recovery chances.
What could go wrong
The tools are still being tested for accuracy in the field, and results may not be conclusive. There is also a risk of false readings, which could affect triage decisions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic brain injury intracranial hypertension stroke disorder subarachnoid hemorrhage traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute brain injury Intracranial hypertension Stroke Subarachnoid hemorrhage Traumatic brain injury

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.