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Custom skull cap may stop brain sinking after Life-Saving surgery

NCT ID NCT06899711

Disease control Sponsor: Johns Hopkins University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a custom 3D-printed external skull cap can prevent Sunken Flap Syndrome, a condition where the brain sinks after part of the skull is removed. 72 patients who had decompressive craniectomy will either wear the cap or not, and researchers will compare brain function and recovery. The goal is to see if the cap protects the brain and reduces the need for extra medical care.

What this could mean

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

Active substance
External cranial prosthesis (3D-printed external skull plate)
What this could lead to
If it works, this could prevent Sunken Flap Syndrome after skull-removal surgery, reducing brain function decline and healthcare costs.
What could go wrong
This is a small, early-stage study with only 72 participants. The device may cause discomfort or not prevent the syndrome, and results may not apply to all patients.

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 72 people

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

Started

Apr 2025

Expected to finish

Apr 2028

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 * Patients must be admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center * Patients must have undergone decompressive hemicraniectomy within 2 weeks of consent for inclusion in the study (before the initial 2 week post-craniectomy assessment) Exclusion Criteria: * Patients that undergo bilateral decompressive hemicraniectomy * Patients that undergo suboccipital decompressive craniectomy * Patients with pre-existing diagnosis of hydrocephalus * Patients with a ventriculoperitoneal, ventriculoatrial, or other permanent cerebrospinal fluid shunt * Patients with an open external ventricular drain at the time of their 2 week post-craniectomy assessment

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic ischemic stroke traumatic brain injury

As listed by the trial registrant

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

Craniectomy Ischemic stroke Traumatic brain injury (TBI) patients Trephined syndrome

How to take part

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

  1. The places running it

    2 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

  • Johns Hopkins Bayview Medical Center

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

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