External Cranial Prosthesis for Trephined Syndrome

(ExO-Skull Trial)

Recruiting at 1 trial location

Overseen By Fernando Gonzalez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Bilateral hemicraniectomy, Hydrocephalus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a custom-made skull prosthetic (external cranial prosthesis) can prevent Sunken Flap Syndrome, a condition that may occur after decompressive hemicraniectomy. This condition can cause symptoms such as headaches, weakness, and seizures. The researchers aim to determine if the prosthetic can improve brain recovery and reduce healthcare costs. Individuals who have recently undergone this specific brain surgery at Johns Hopkins and do not have certain other medical conditions may qualify for the trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery and reduce costs for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with your doctor to ensure your safety during the trial.

What prior data suggests that this prosthetic device is safe for preventing Sunken Flap Syndrome?

Studies have shown that a 3D-printed external cranial prosthesis, a custom-made protective cover for the skull, is safe and effective. It reduces complications after brain surgery where part of the skull is removed, such as in decompressive craniectomy. Patients using these prosthetics report fewer issues, including the prevention of Sunken Flap Syndrome, where the brain sinks into the skull due to missing bone.

Research indicates that patients tolerate these prosthetics well, experiencing minimal side effects like discomfort or itching. Any issues that arise are usually minor and manageable. Overall, evidence suggests that the external cranial prosthesis is a safe option for those recovering from this type of surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the External Cranial Prosthesis (ECP) for Trephined Syndrome because it offers a novel approach to post-operative care. Unlike the standard treatment options, which primarily involve regular neurologic assessments and monitoring, the ECP is a physical prosthesis worn by the patient. This device aims to potentially improve outcomes by stabilizing the skull and enhancing blood flow in the brain, as measured by trans-cranial duplex ultrasonography. By directly addressing the physical changes following skull surgery, the ECP could add a new dimension to patient recovery and quality of life.

What evidence suggests that this prosthetic device is effective for preventing Sunken Flap Syndrome?

Research has shown that using an external head covering can help prevent Sunken Flap Syndrome (SFS) in patients who have had part of their skull removed. In this trial, participants who choose to wear the External Cranial Prosthesis (ECP) will receive it at their 4-week post-operative appointment. Studies have found that a temporary plaster helmet can safely and effectively treat severe SFS. This method improves blood flow in the brain, aiding recovery and brain function. By supporting the area where the skull is missing, the head covering helps the brain stay in its normal position, potentially reducing problems like headaches and weakness. Early reports suggest that these coverings may also reduce the need for additional medical visits, potentially lowering healthcare costs. ^{2 3 6 7 8}

Who Is on the Research Team?

Fernando Gonzalez, MD

Principal Investigator

Johns Hopkins University

Joseph M Dardick, MD

Principal Investigator

Johns Hopkins Medical Institute

Are You a Good Fit for This Trial?

This trial is for patients who have had a decompressive craniectomy due to traumatic brain injury, stroke, or brain bleed and are at risk of developing Sunken Flap Syndrome. Participants or their medical decision-makers must consent to the study and agree to wear a custom-made external cranial prosthesis if chosen.

Inclusion Criteria

I am older than 18 years.

Patients must be admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center

I had surgery to remove part of my skull due to pressure on my brain within the last 2 weeks.

Exclusion Criteria

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

I have had surgery to relieve pressure on my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-operative Care

Participants receive standard post-operative care and appointments at 2 and 4 weeks after decompressive craniectomy (DC) surgery. Participants who agree to wear the prosthetic receive it at the 4-week post-DC appointment.

4 weeks

2 visits (in-person)

Prosthetic Use and Monitoring

Participants who receive the prosthetic are asked to wear it as much as possible and report any issues. All participants undergo non-invasive brain function testing at each appointment.

Up to 6 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pre- and post-cranioplasty appointments.

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• External Cranial Prosthesis

Trial Overview The study tests whether an external cranial prosthesis can prevent Sunken Flap Syndrome in patients after decompressive craniectomy. It also examines if the prosthetic improves brain function recovery and reduces healthcare costs. Patients will be monitored through regular appointments and non-invasive brain health testing.

How Is the Trial Designed?

Group I: External Cranial Prosthesis (ECP) Experimental Treatment 1 Intervention

Patients that agree to participate in wearing the post-operative skull prosthesis will receive the prosthesis at their 4 week post-operative appointment. At this time, the participant will be asked to wear the prosthesis at all times, as much as the participant is able, and to notify the investigators of any pain, itching, discomfort, or other problems with the prosthesis. These patients will receive a neurologic assessment at this 4-week appointment and will also receive their standard-of-care 2-week post-craniectomy and pre- and post-cranioplasty appointments with neurologic assessments. In addition to these neurologic assessments, the participant will receive trans-cranial duplex ultrasonography to measure the blood flow velocities in their middle cerebral arteries at each appointment. Finally, patients' will receive a survey at their post-cranioplasty appointment with questions regarding their experience with the external cranial prosthesis.

Group II: No Prosthesis Active Control 1 Intervention

Patients that elect not to wear the post-operative skull prosthesis will receive standard-of-care treatment which includes 2-week and 4-week post-operative appointments with neurologic assessments and pre- and post-cranioplasty appointments with neurologic assessments. In addition to their neurologic assessment, the participant will also receive trans-cranial duplex ultrasonography to measure the blood flow velocities in their middle cerebral arteries at each appointment.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2214751920306265

External cranioplasty for the syndrome of the trephined The making of a plaster helmet has proved to be an effective and safe temporary treatment for severe cases of trephined syndrome that require prompt ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06899711?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(cranial%20syndrome%20OR%20%22alopecia-deafness-hypogonadism%20syndrome%22%20OR%20%22%20alopecia-sensorineural%20deafness-hypogonadism%20syndrome%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING))&rank=4

External Post-Operative Skull Prosthesis to Prevent ... Patients that undergo decompressive craniectomy are at risk of delayed changes in brain function known as "Sunken Flap Syndrome" or "Syndrome of the Trephined.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10718283/

a novel temporizing approach to acute sinking skin flap ... This report describes the use of a novel approach to address acute sinking skin flap syndrome (SSFS), a postcraniectomy complication arising from brain ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/01616412.2024.2448632?src=exp-la

Revisiting sinking skin flap syndrome: a series of case ... The results showed significant improvements in cerebral blood flow perfusion in specific cortical areas after cranioplasty [Citation27]. Luca and colleagues ...

5. journals.lww.com journals.lww.com/10.1097/SCS.0000000000011812

Temporary Skin Lifting Using Elastic Traction for Sinking... This case highlights the potential utility of elastic traction-based skin elevation as a safe and effective bridge therapy in SSFS management ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11630915/

Safety and efficacy of a 3D-printed external cranial ... The clinical use of the 3D-printed ECPD is safe and reliable, effectively reducing the incidence of complications following DC, particularly in the prevention ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0258296

3D-printed external cranial protection following ... Outcomes during FU included; reported wearing time/day (hours), subjective pain, discomfort, pruritus, dislodgment, cosmesis ratings; and observed wound changes ...

8. researchgate.net researchgate.net/publication/386600402_Safety_and_efficacy_of_a_3D-printed_external_cranial_protection_device_in_preventing_complications_after_unilateral_supratentorial_decompressive_craniectomy_A_retrospective_cohort_study

(PDF) Safety and efficacy of a 3D-printed external cranial ... Clinical data were collected and analyzed. Forty-four patients were enrolled, 24 in the experimental and 20 in the control group. The incidence ...