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External Cranial Prosthesis for Sunken Flap Syndrome

This study is looking into whether an External Cranial Prosthesis, a 3D printed plate, can help prevent "Sunken Flap Syndrome" (a change in brain function after skull surgery) in patients who have had a craniectomy. Patients who have experienced traumatic brain injury or stroke and had a craniectomy within the last two weeks at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center may be able to join. The study aims to see if this prosthesis can prevent the syndrome, reduce healthcare costs, and improve brain function recovery. The study plans to enroll 72 participants.

Study design
This interventional study plans to enroll 72 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, incidence of Sunken Flap Syndrome, will be measured for up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06899711

External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients

Recruiting
NAAges 18+InterventionalPrevention
Johns Hopkins University
~72 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:External Cranial Prosthesis

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Sunken Flap Syndrome
Measured over Up to 6 months

Conditions

Craniectomy
Trephined Syndrome
Traumatic Brain Injury (TBI) Patients
Ischemic Stroke

Explore related trials

Ischemic StrokeSyndrome of the TrephinedTraumatic Encephalopathy

Where it's being run

2 sites across 1 states
Maryland2

Study leadership

  • Joseph M Dardick, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins Medical Institute
  • Fernando Gonzalez, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Joseph M Dardick, MD
[email protected]
314-249-4648
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Sunken Flap SyndromeUp to 6 months

    Sunken Flap Syndrome will be defined as development of new neurologic symptoms after acute injury and craniectomy that improve quickly post-cranioplasty (ie. between pre- and post-cranioplasty appointments). Changes will be determined based on Glasgow coma scale, brainstem reflex assessment, confrontational strength testing, and Mini-Mental State Exam testing (MMSE). Patients that have improvement in at least one of these modalities will indicate that the patient suffered from SFS and the reported variable will be "incidence of SFS". The incidence of SFS will be compared between the intervention and non-intervention groups using chi-squared analysis.