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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
Study Summary
This trial studies the effects of ultrasound on the skull to treat brain injury. It's a real-world study, with open results.
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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic accuracy of TCUS
Identification of Neuroanatomy accuracy of TCUS
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.
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.
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Who is running the clinical trial?
Northwell HealthLead Sponsor
461 Previous Clinical Trials
471,085 Total Patients Enrolled
Netanel Ben-Shalom, MDPrincipal InvestigatorLenox Hill Hospital
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