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

Trial Summary

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.

Is the External Cranial Prosthesis generally safe for humans?

Cranioplasty, which involves placing an artificial plate to repair skull defects, has some safety concerns. The most common issues are infections and improperly fitting implants, with other complications like fluid leakage and implant breaks also reported. ^{1 2 3 4 5}

How does the external cranial prosthesis treatment differ from other treatments for trephined syndrome?

The external cranial prosthesis is unique because it offers a temporary solution for trephined syndrome when immediate cranioplasty (surgical repair of the skull) is not possible, such as in cases of infection. This approach uses a custom-made device to prevent symptoms until a permanent solution can be applied, unlike the standard treatment which involves immediate bone flap replacement. ^{1 6 7 8 9}

What is the purpose of this trial?

Patients that undergo decompressive craniectomy are at risk of delayed changes in brain function known as "Sunken Flap Syndrome" or "Syndrome of the Trephined." The goal of this clinical trial is to see if placing a prosthetic over patients' skull defects can prevent "Sunken Flap Syndrome." The main questions are: 1. Can placing a prosthetic device over patients' skull defects prevent Sunken Flap Syndrome? 2. Can placing a prosthetic device over patients' skull defects decrease healthcare costs? 3. Can placing a prosthetic device over patients' skull defects improve recovery and return of brain function after decompressive craniectomy? Patients that experience traumatic brain injuries, brain bleeds, and large strokes can build up high levels of pressure in the skull. When this pressure can't be controlled with medications, a life-saving surgery called a decompressive hemicraniectomy (DC) is often performed. In this surgery, a large portion of the patient's skull is removed to decrease pressure on the brain and decrease permanent damage. After this surgery, many patients experience sinking of the brain in the skull as the pressure inside the head improves. The skull normally protects the brain from the outside environment. When large parts of the skull are removed, the brain is not able to regulate itself normally. This can lead to a number of problems, such as headaches, weakness, seizures, and even coma and permanent brain damage. This is referred to as "Sunken Flap Syndrome" (SFS) or "Syndrome of the Trephined" (SoT). After 3-6 months, patients can have the missing skull surgically repaired, which improves and sometimes fixes SFS, but the damage is sometimes too severe to be reversed. There are reports of patients with SFS treated with custom-made prosthetics that cover the missing piece of skull. In this study, the researchers want to see if wearing a custom-made prosthetic can prevent patients from experiencing SFS. Patients will also receive additional non-invasive measurement to see if the prosthetic can improve brain function and recovery. Finally, the researchers want to know if the prosthetic is cost-effective by decreasing the frequency that patients see doctors or receive care to treat SFS. Patients or the patient's medical decision makers will be asked if the patient wants to participate in the study after DC. If the patient or decision maker agrees to participate, the patient will be also asked if the patient wants to wear the prosthetic. The prosthetic is made of a common material used in other facial prosthetics. Patients that agree to wear the prosthetic will have a custom plate made for the participant. All patients will receive the same post-operative care and appointments whether or not the prosthetic is worn. The participant will go to the normally scheduled post-operative doctor's appointments at 2 and 4 weeks after initial DC surgery. Patient's that agree to wear the prosthetic will receive it at the 4-week post-DC appointment. The participant will then be asked to wear it as much as possible, but to let the researchers know if the participant experiences any pain, itching, discomfort or other problems. All patients will also be seen by the patient's physician before and after and after skull repair. At all appointments, patients will receive non-invasive testing of brain function. Recovery and rate of SFS will be compared between patients that do and do not wear the prosthetic. Participants will: * Go to the normally scheduled 2 and 4 week post-DC appointments * Go to the normally scheduled pre- and post-skull repair appointments * Receive additional non-invasive brain health testing at each appointment Participants that agree to wear a prosthetic will: * Receive the custom prosthetic at the 4-week post-DC appointment * Wear the prosthetic as much as possible, including at night * Take a brief survey about the prosthetic at the post-skull repair appointment

Research Team

Joseph M Dardick, MD

Principal Investigator

Johns Hopkins Medical Institute

Fernando Gonzalez, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Novel Temporary Treatment for a Severe Case of Syndrome of Trephined. [2018]

2. Turkey pubmed.ncbi.nlm.nih.gov

Can cranioplasty be effective in improving cognitive and motor function in patients with chronic disorders of consciousness? A case report. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events of Cranioplasty Implants After Craniectomy: A Retrospective Review of the Federal Manufacturer and User Facility Device Experience Database. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Parental satisfaction with the CranioCap: a new cranial orthosis for deformational plagiocephaly. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Subtotal calvarial vault reconstruction utilizing a customized polyetheretherketone (PEEK) implant with chimeric microvascular soft tissue coverage in a patient with syndrome of the trephined: A case report. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Syndrome of the trephined following bifrontal decompressive craniectomy: implications for rehabilitation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Craniofacial implant surgery. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Craniofacial implant surgery. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Orthostatic mesodiencephalic dysfunction after decompressive craniectomy. [2022]