What side effects are associated with this type of intervention?

Common treatments for cranioplasty, including the use of sonolucent materials for procedures like Transcranial Ultrasound, can have several side effects. These may include infection, bleeding, and complications related to the implant such as material rejection or displacement. Additionally, patients may experience headaches, swelling, and in rare cases, seizures. The use of sonolucent materials specifically aims to minimize some of these risks by allowing non-invasive diagnostic and therapeutic procedures, but the general surgical risks remain.

What prior FDA approvals exist?

The FDA has approved various materials for cranioplasty, including autologous bone, polymethylmethacrylate (PMMA), and titanium, which are commonly used to repair skull defects. While specific FDA approvals for the use of sonolucent materials in conjunction with transcranial ultrasound are not detailed, the concept is being explored in clinical trials. These trials aim to utilize ultrasound waves passing through sonolucent cranioplasty materials for diagnostic or therapeutic purposes, potentially enhancing brain imaging and treatment delivery.

What other types of research exist?

Promising alternatives to Transcranial Ultrasound for cranioplasty patients include the use of implantable ultrasound devices for repeated disruption of the blood-brain barrier, and advanced cochlear implantation techniques such as the trans-aditus approach. These methods offer innovative diagnostic and therapeutic benefits for patients.

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Transcranial Ultrasound for Cranioplasty

N/A

Recruiting

Led By Netanel Ben-Shalom, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are undergoing reconstructive sonolucent cranioplasty as standard of care

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to use ultrasound to look inside the brain through a special see-through part of the skull in patients who have had skull repair surgery. This method aims to be safer and easier than traditional brain imaging techniques like CT and MRI scans.

Who is the study for?

This trial is for men and women aged 18 or older who are undergoing reconstructive sonolucent cranioplasty as standard care. Participants must be willing to follow study procedures and be available for the entire study duration. Pregnant individuals cannot participate.

What is being tested?

The trial is observing how transcranial ultrasound works when used through a sonolucent (sound-transparent) material during cranioplasty, which is skull reconstruction surgery. It's an open-label study, meaning everyone knows what treatment they're getting.

What are the potential side effects?

Since this trial focuses on observation of transcranial ultrasound in a surgical setting rather than testing a new drug, specific side effects related to medications are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a skull reconstruction with a transparent implant as part of my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic accuracy of TCUS

Identification of Neuroanatomy accuracy of TCUS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcranial UltrasoundExperimental Treatment1 Intervention

Ultrasound imaging will be performed by clinicians using FDA-approved ultrasound devices currently used in routine clinical practice.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cranioplasty involves the surgical repair of a bone defect in the skull, often using materials that can integrate with the bone. Transcranial ultrasound via sonolucent cranioplasty uses materials that allow ultrasound waves to pass through the repaired area, enabling non-invasive diagnostic and therapeutic procedures. This method is significant for cranioplasty patients as it provides a means to monitor brain health and deliver treatments without additional invasive surgeries, potentially reducing recovery time and improving overall outcomes.