Transcranial Ultrasound for Cranioplasty

Overseen By Tamika Wong, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Pregnancy

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather real-world evidence on using transcranial ultrasound through a special type of skull reconstruction called sonolucent cranioplasty. It focuses on patients already undergoing this specific type of cranioplasty to evaluate the effectiveness of ultrasound imaging in these cases. Participants should be adults receiving this skull surgery as part of their regular medical care. As an unphased trial, the study offers patients the opportunity to contribute to innovative research that could enhance future medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transcranial ultrasound is safe for cranioplasty?

Research has shown that transcranial ultrasound, used in various medical settings, is generally easy for patients to handle. Studies have found it to be a non-invasive and helpful tool for assessing brain conditions. Many doctors frequently use it in emergency care and to evaluate brain injuries. Patients might feel slight discomfort or pressure where the ultrasound is applied, but serious side effects are rare. Importantly, the FDA has approved the ultrasound devices used in this study, and they are commonly used in medical practice, suggesting that the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial ultrasound for cranioplasty because it offers a non-invasive imaging option that can potentially improve surgical outcomes. Unlike traditional methods, which may rely heavily on CT or MRI for imaging, transcranial ultrasound provides real-time, dynamic images without exposing patients to radiation. This approach could make surgeries safer and more efficient by allowing surgeons to monitor and adjust procedures on the fly. Additionally, it uses FDA-approved ultrasound devices that are already trusted in clinical practice, potentially making it a more accessible and cost-effective alternative.

What evidence suggests that transcranial ultrasound is effective for cranioplasty?

Research has shown that transcranial ultrasound, which participants in this trial will receive, can enhance brain function after cranioplasty, a surgery to repair the skull. Studies have found that this method safely tracks changes in blood flow to the brain, which is crucial for recovery. In individuals with traumatic brain injuries, transcranial ultrasound has proven beneficial for both immediate and long-term care. Evidence suggests that using ultrasound during cranioplasty may improve recovery by boosting blood flow and aiding brain healing. ^{1 3 4 6 7}

Who Is on the Research Team?

Netanel Ben-Shalom, MD

Principal Investigator

Lenox Hill Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have provided a signed and dated declaration of consent.

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

I am willing and able to follow all study rules and attend all appointments.

Exclusion Criteria

Patients who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Ultrasound imaging performed using FDA-approved devices to assess feasibility and efficacy compared to standard postoperative imaging

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Ultrasound

Trial Overview

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.

How Is the Trial Designed?

Group I: Transcranial Ultrasound Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

Using 3-dimensional graphical reconstructions of patients' skulls can significantly improve the success rates of transcranial Doppler ultrasound (TCD) procedures performed post-surgery, especially in challenging cases.

The image guidance not only enhances operator confidence but also reduces the time needed to complete the TCD, making it a valuable tool in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guidance for rapid temporal acoustic window localisation prior to transcranial Doppler ultrasound in the neurosurgical patient. Lewis, PM., Goldschlager, T., Rosenfeld, JV.[2016]

Decompressive craniectomy (DC) significantly reduces intracranial pressure (ICP) from an average of 37 mm Hg to 20 mm Hg immediately after the procedure, indicating its efficacy in managing severe traumatic brain injury (TBI).

The procedure also leads to improved cerebral blood flow, with diastolic velocities increasing and pulsatility index decreasing, suggesting a normalization of cerebral hemodynamics that lasts for at least 48 hours post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral hemodynamic changes in severe head injury patients undergoing decompressive craniectomy. Daboussi, A., Minville, V., Leclerc-Foucras, S., et al.[2010]

Transcranial Doppler ultrasonography (TCD) is an effective tool for assessing changes in cerebral blood flow, which is crucial for understanding both normal and abnormal brain function.

TCD can be used to measure cerebrovascular reactivity in response to various physiological and pathological stimuli, highlighting its importance in clinical evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Investigation of cerebrovascular reactivity using transcranial doppler ultrasonography]. Sapieja, W.[2015]

Transcranial Doppler (TCD) ultrasonography is a valuable noninvasive tool for evaluating intracranial blood flow in patients with acute ischemic stroke, providing real-time hemodynamic information that can enhance treatment planning and monitoring.

TCD can monitor the effectiveness of thrombolysis treatments, such as tissue plasminogen activator (TPA), and has potential applications in detecting emboli and assessing cerebrovascular responses, making it essential in comprehensive stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of transcranial Doppler ultrasonography in acute stroke. Sharma, VK., Venketasubramanian, N., Khurana, DK., et al.[2022]

Transcranial Doppler (TCD) ultrasonography can effectively predict outcomes in patients with severe traumatic brain injury, with significant correlations found between TCD measurements and intracranial pressure (ICP) and cerebral perfusion pressure (CPP).

In a study of 96 patients, those with a mean blood flow velocity greater than 40 cm/s and a pulsatility index lower than 1.5 within the first 24 hours had better outcomes at 6 months, indicating that TCD can be a valuable tool in assessing the severity of brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome prediction in severe traumatic brain injury with transcranial Doppler ultrasonography. Tan, H., Feng, H., Gao, L., et al.[2016]

In a study of 318 patients undergoing carotid endarterectomy (CEA), significant increases in middle cerebral artery flow velocity (MCAFV) were observed postoperatively, particularly in the first systolic peak (Sys1) and second systolic peak (Sys2), indicating improved blood flow to the brain.

The study found that while Sys1 and Sys2 increased significantly after surgery, diastolic flow velocity decreased, suggesting a normalization of arteriolar resistance, which could help identify potential complications like hyperperfusion syndrome in future assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age corrected changes in intracranial hemodynamics after carotid endarterectomy. Schaafsma, M., Glade, GJ., Keller, PJ., et al.[2021]

Transcranial Doppler (TCD) ultrasound, when used alongside near-infrared spectroscopy (NIRS), can effectively identify different causes of cerebral desaturation during surgery, as demonstrated in a case involving a 69-year-old male patient undergoing heart surgery.

The study revealed that TCD can detect significant air emboli during episodes of brain desaturation, which were linked to acute right ventricular dysfunction, highlighting the importance of multimodal monitoring in improving patient safety and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proposed algorithm for combining transcranial Doppler ultrasound monitoring with cerebral and somatic oximetry: a case report. Azzam, MA., Couture, EJ., Beaubien-Souligny, W., et al.[2021]

Sonolucent cranial implants, particularly those made from clear poly-methyl-methacrylate (PMMA), allow for effective ultrasound imaging of the brain, providing a new way to monitor intracranial conditions post-surgery.

Intraoperative and postoperative ultrasound evaluations demonstrated that these implants can reveal detailed ventricular anatomy and detect complications like epidural fluid collections, suggesting their potential for real-time monitoring of brain health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sonolucent Cranial Implants: Cadaveric Study and Clinical Findings Supporting Diagnostic and Therapeutic Transcranioplasty Ultrasound. Belzberg, M., Shalom, NB., Yuhanna, E., et al.[2023]

Transcranial Doppler (TCD) ultrasonography is a valuable tool in critical care for assessing cerebral blood flow, particularly in cases of cerebral vasospasm after subarachnoid hemorrhage, but its effectiveness in improving patient outcomes remains unclear due to a lack of randomized controlled studies.

Recent technological advancements in TCD, such as M mode and three-dimensional power Doppler, have expanded its applications beyond critical care, including the assessment of cerebral emboli and management of sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of transcranial Doppler in the ICU: a review. White, H., Venkatesh, B.[2018]

Transcranial Doppler ultrasonography (TCD) is a safe, noninvasive, and cost-effective method for assessing intracranial pressure (ICP) in children with craniosynostosis, evaluated in a study of 16 children.

While TCD did not correlate well with traditional ICP measurements or CT findings, a decrease in the pulsatility index (PI) after surgery was clinically useful, indicating successful decompression, while an increase in PI post-surgery was a concerning sign.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of transcranial Doppler ultrasonography in craniosynostosis. Govender, PV., Nadvi, SS., Madaree, A.[2019]

Transcranial Doppler (TCD) ultrasonography is a valuable noninvasive tool for continuously monitoring cerebral blood flow (CBF) during surgery, which is crucial for patients at risk of cerebral ischemia.

The ongoing refinement of TCD technology aims to enhance its effectiveness and establish clear guidelines for its use as an intraoperative monitoring device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative use of transcranial Doppler ultrasonography. Lam, AM., Newell, DW.[2016]

In a study of 11 children with craniostenosis, decompression surgery significantly improved cerebral blood flow velocities in younger patients (ages 0-3 and 4-7), indicating enhanced cerebral hemodynamics post-surgery.

Transcranial Doppler sonography (TCD) proved to be an effective noninvasive method for monitoring changes in cerebral blood flow, demonstrating that surgery had a positive impact on blood flow parameters, particularly in younger children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative and postoperative transcranial Doppler sonographic evaluations of the cerebral hemodynamics of craniostenosis. Wang, B., Cheng, Z., Mu, X., et al.[2016]

In a study of 54 patients undergoing cranioplasty, 42.6% showed objective neurological improvement within 72 hours after the procedure, suggesting that cranioplasty may enhance brain function beyond cosmetic correction.

Post-surgery, there was a significant increase in cerebral blood flow (CBF) on both the defective side and the healthy side, with larger variations in the Lindegaard ratio indicating potential predictors of clinical improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Cranioplasty on Cerebral Hemodynamics as Measured by Perfusion Computed Tomography and Doppler Ultrasonography. Paredes, I., Castaño, AM., Cepeda, S., et al.[2018]

Citations

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pmc.ncbi.nlm.nih.gov

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Transcranial ultrasound in the critically ill patient

In this review, we discuss some important origins of more modern composite techniques and highlight relevant major key concepts, whilst noting ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0967586803003400

Clinical study Neurological improvement after cranioplasty

Postoperative changes in neurological status and blood flow velocity were examined and compared using transcranial Doppler (TCD) sonography. The mean interval ...

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j-nn.org

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Transcranial Doppler Ultrasound Role for Patients with ...

This review summarizes the advantages and the specific roles of TCD ultrasonography for patients with acute and long-term effects of TBI. Key ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11806159/

Technical Considerations in the TCD Evaluation of Cerebral ...

Transcranial Doppler ultrasound (TCD) has been recommended as an ancillary test; however, the technical descriptions have been heterogeneous.

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withpower.com

withpower.com/trial/phase-cranioplasty-5-2023-1049b

Transcranial Ultrasound for Cranioplasty

Transcranial Doppler sonography (TCD) proved to be an effective noninvasive method for monitoring changes in cerebral blood flow, demonstrating that surgery ...

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journals.lww.com/neur/fulltext/2022/70050/role_of_bedside_transcranial_ultrasonography_in.15.aspx

Role of Bedside Transcranial Ultrasonography in the...

Studies on Cranioplasty and Transcranial Doppler. Clinical, neurological, and cognitive outcomes were assessed by the Glasgow Outcome Scale (GOS). Majority ...

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Transcranial sonography: practical use in the intensive ...

Brain ultrasonography has emerged as a valuable diagnostic and monitoring tool in intensive care, complementing other point-of-care techniques.