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

NCT ID NCT06899711

Recruiting now Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

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.

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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

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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