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New device could spot dangerous brain pressure without needles

NCT ID NCT07210333

Diagnosis Sponsor: Braincare USA Corp 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will check if a non-invasive device can accurately detect high pressure inside the skull in 300 adults with traumatic brain injury or stroke. The device uses a sensor placed on the head to measure brain pressure and pulse waves. If successful, it could help doctors make faster decisions and reduce the need for invasive tests in emergency rooms.

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.

Participants

About 300 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Adult patients (≥18 years) of both sexes presenting with clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic). Participants will be recruited from multiple levels of care within the Brazilian Unified Health System (SUS), including primary care units (UBS), urgent care units (UPA), pre-hospital emergency services (SAMU), hospital emergency rooms (PS), and intensive care units (ICUs) at participating hospitals in the states of Amazonas, São Paulo, Sergipe, and Rio Grande do Sul.

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 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. Exclusion Criteria Individuals with brain lesions of other etiologies, such as previous TBI and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, or illicit drug use. Individuals with scalp or skin lacerations that prevent proper placement of the brain4care sensor. Individuals with craniectomy or skull fractures. Individuals with severe debilitating mental health disorders and/or severe debilitating neurological diseases. Individuals who are agitated, aggressive, or uncooperative, preventing follow-up and outcome assessment. Pregnant women.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic hemorrhagic stroke intracerebral hemorrhage ischemic stroke stroke disorder traumatic brain injury

As listed by the trial registrant

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

Stroke hemorrhagic Stroke, ischemic Traumatic brain injury (TBI) patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Hospital São Paulo

    São Paulo, São Paulo, 04024-002, Brazil

  • Hospital Universitário Getúlio Vargas

    Manaus, Amazonas, 69020-170, Brazil

  • Hospital Universitário de Lagarto

    Lagarto, Sergipe, 49400-000, Brazil

More trials for these conditions

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