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New study aims to spot brain swelling without drilling into the skull

NCT ID NCT06504238

Knowledge-focused Sponsor: Boston Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing several non-invasive methods—like pupil checks, EEG, and ultrasound—to see if they can detect life-threatening brain swelling earlier than current methods. Researchers will monitor 720 patients with acute brain injuries in the ICU. The goal is to find reliable, easy-to-use tools that could speed up treatment and improve outcomes.

What this could mean

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

What this could lead to
If successful, this could lead to better, faster detection of dangerous brain swelling without invasive procedures, potentially saving lives and reducing disability.
What could go wrong
This is an observational study, not a treatment trial. The methods are still being tested for accuracy, and results may not change current care immediately.

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 720 people

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

Started

Sep 2024

Expected to finish

Sep 2030

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.

Who is studied

Eligible patients will be recruited on admission to the intensive care unit (ICU) at Boston Medica Center followed by the Neurointensive care team.

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: * Admitted under Neuro intensivist primary or consultative care. * At least one head computed tomography (CT) scan demonstrating intracranial pathology that may lead to life-threatening mass effect (i.e. traumatic brain injury, ischemic or hemorrhagic stroke, epidural or subdural hematoma, subarachnoid hemorrhage, diffuse hypoxic injury, metabolic cerebral edema, tumor) * Concern for Life Threatening Mass Effect * Glasgow Coma Score (GCS) \<9 * Anticipated stay \>24 hours Exclusion Criteria: * Comfort measure only * Any other criteria that the PI deems that makes the patient inadequate for the study * Sub-exclusion criteria for specific non-invasive measurements include: * Orbital injury (pupillometry, ONSD) * Traumatic injury or surgery that precludes use of B4C device * Presence of supratentorial craniectomy or craniotomy that has not healed and is mobile/bone defects/scalp injury \[EEGelectroencephalogram (EEG), Brain4Care\] * Presence of extensive scalp injury

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic brain injury Ischemic Stroke

As listed by the trial registrant

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

Brain injury, acute

How to take part

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

  1. The places running it

    1 site. 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

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States