Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment Transcranial Ultrasound for Cranioplasty?
Research shows that using transcranial Doppler ultrasonography (a type of ultrasound) can help monitor changes in blood flow in the brain before and after surgeries like cranioplasty. This method is noninvasive and has been useful in assessing improvements in brain blood flow and predicting clinical outcomes after surgery.
12345Is transcranial ultrasound generally safe for humans?
Transcranial Doppler ultrasound (TCD) is a noninvasive procedure widely used in neurology and neurosurgery to monitor blood flow in the brain. It is considered safe and is commonly used in various settings, including during surgery and in emergency situations, without significant safety concerns reported.
678910How is transcranial ultrasound for cranioplasty different from other treatments?
Transcranial ultrasound for cranioplasty is unique because it uses sonolucent (ultrasound-transparent) cranial implants to allow ultrasound imaging of the brain after surgery, providing a non-invasive way to monitor brain health at the bedside. This approach differs from traditional methods that require direct access to the brain during surgery for imaging.
89111213Eligibility Criteria
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 18 years old or older.
+1 more
Exclusion Criteria
Patients who are pregnant
Trial Timeline
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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lenox Hill HospitalNew York, NY
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Who Is Running the Clinical Trial?
Northwell HealthLead Sponsor
References
The value of transcranial Doppler ultrasonography in craniosynostosis. [2019]Some children with craniosynostosis demonstrate raised intracranial pressure (ICP), requiring surgical decompression. Conventional methods of measuring ICP in such children are invasive, expensive, and require expertise. Transcranial Doppler ultrasonography (TCD) is an alternative, useful means of assessing ICP qualitatively, and is noninvasive, inexpensive, and safe. We evaluated the use of TCD prospectively in 16 children with craniosynostosis and correlated TCD findings with intraoperative ICP measurements by lumbar puncture (LP) and with computed tomographic (CT) findings. TCD evaluations were performed before and after surgery to determine the pulsatility index (PI), which is known to show close correlation with ICP. The three modalities--TCD, ICP, and CT--showed poor correlation with each other. However, the fall in the PI value after surgery, as determined by TCD, was shown to be clinically useful, with a rise in the PI value after surgery being an ominous sign.
Preoperative and postoperative transcranial Doppler sonographic evaluations of the cerebral hemodynamics of craniostenosis. [2016]Making use of transcranial Doppler sonographic (TCD) technology to monitor the preoperative and postoperative changes in cerebral hemodynamics of sick children with craniostenosis and to evaluate the effects brought about by decompression surgery of craniostenosis by means of various changes in the parameters of cerebral blood flow.
Cerebral hemodynamic changes in severe head injury patients undergoing decompressive craniectomy. [2010]To assess the intracranial hemodynamic modifications induced by a decompressive craniectomy (DC) after severe traumatic brain injury (TBI), using transcranial Doppler (TCD) ultrasonography and intracranial pressure (ICP) sensor. Mortality rate and neurological outcomes were also evaluated after this procedure.
Outcome prediction in severe traumatic brain injury with transcranial Doppler ultrasonography. [2016]To investigate the value of transcranial Doppler (TCD) ultrasonography in evaluating the outcome of severe traumatic brain injury and to correlate the TCD values with intracranial pressure (ICP) and cerebral perfusion pressure (CPP) monitoring.
The Effect of Cranioplasty on Cerebral Hemodynamics as Measured by Perfusion Computed Tomography and Doppler Ultrasonography. [2018]Cranioplasties are performed to protect the brain and correct cosmetic defects, but there is growing evidence that this procedure may result in neurological improvement. We prospectively studied cranioplasties performed at our hospital over a 5-year period. The National Institute of Health Stroke Scale and Barthel index were recorded prior to and within 72 h after the cranioplasty. A perfusion computed tomography (PCT) and transcranial Doppler sonography (TCDS) were performed prior to and 72 h after the surgery. For the PCT, regions irrigated by the anterior cerebral artery, the middle cerebral artery (MCA), the posterior cerebral artery, and the basal ganglia were selected, as well as the mean values for the hemisphere. The sonography was performed in the sitting and the supine position for the MCA and internal carotid. The velocities, pulsatility index, resistance index, and Lindegaard ratio (LR) were obtained, as well as a variation value for the LR (ΔLR = LR sitting - LR supine). Fifty-four patients were included in the study. Of these, 23 (42.6%) patients presented with objective improvement. The mean cerebral blood flow of the defective side (m-CBF-d) increased from 101.86 to 117.17 mL/100 g/min (p = 0.064), and the m-CBF of the healthy side (m-CBF-h) increased from 128.14 to 145.73 mL/100 g/min (p = 0.028). With regard to the TCDS, the ΔLR was greater on the defective side prior the surgery in those patients who showed improvement (1.295 vs. -0.714; p = 0.002). Cranioplasty resulted in clinical improvement in 40% of the patients, with an increase in the post-surgical CBF. The larger variations in the LR when the patient is moved from the sitting to the supine position might predict the clinical improvement.
Image guidance for rapid temporal acoustic window localisation prior to transcranial Doppler ultrasound in the neurosurgical patient. [2016]Transcranial Doppler ultrasound (TCD) is a technically challenging procedure, when performed at the bedside in the postoperative period. Skull defects and acoustic obstacles were identified prior to TCD using 3-dimensional graphical reconstructions of patients' skulls after aneurysm surgery. We report our experiences, including a case wherein the technique facilitated completion of a successful TCD after conventional methods failed. We conclude that image guidance improves success rates, increases operator confidence and decreases procedural time for transcranial Doppler ultrasound.
Age corrected changes in intracranial hemodynamics after carotid endarterectomy. [2021]Transcranial Doppler ultrasound (TCD) is a frequently used method to monitor brain perfusion during and following carotid endarterectomy (CEA). Our aim was to define the normally occurring changes of intracranial hemodynamics in patients undergoing CEA measuring recently developed TCD parameters.
Intraoperative use of transcranial Doppler ultrasonography. [2016]Transcranial Doppler (TCD) ultrasonography is a diagnostic tool that is well established in the fields of neurology and neurosurgery. There are many potential applications of TCD ultrasonographic monitoring in the perioperative care of the patient at risk of cerebral ischemia, the most important of which are detailed in this article. The introduction of TCD ultrasonography has made it possible to monitor intraoperative CBF changes in a continuous, noninvasive manner. Further refinement in the technology will delineate its appropriate use as an intraoperative monitor.
[Investigation of cerebrovascular reactivity using transcranial doppler ultrasonography]. [2015]Transcranial Doppler ultrasonography (TCD) is the most useful method for evaluation of relative changes of cerebral blood flow. This features was used in the investigations measuring cerebrovascular reactivity for physiological and pathological impulses.
Role of transcranial Doppler ultrasonography in acute stroke. [2022]Transcranial Doppler (TCD) ultrasonography is the only noninvasive examination that provides a reliable evaluation of intracranial blood flow patterns in real-time, adding physiological information to the anatomical information obtained from other neuroimaging modalities. TCD is relatively cheap, can be performed bedside, and allows monitoring both in acute emergency settings as well as over prolonged periods; it has a high temporal resolution, making it ideal for studying dynamic cerebrovascular responses.
A proposed algorithm for combining transcranial Doppler ultrasound monitoring with cerebral and somatic oximetry: a case report. [2021]Transcranial Doppler (TCD) ultrasound is a non-invasive monitor of cerebral blood velocity that can be used intraoperatively. The purpose of this report is to describe how different patterns seen on TCD can help identify the cause of cerebral desaturation when near-infrared spectroscopy (NIRS) oximetry is used concomitantly.
Applications of transcranial Doppler in the ICU: a review. [2018]Transcranial Doppler (TCD) ultrasonography is a technique that uses a hand-held Doppler transducer (placed on the surface of the cranial skin) to measure the velocity and pulsatility of blood flow within the intracranial and the extracranial arteries. This review critically evaluates the evidence for the use of TCD in the critical care population.
Sonolucent Cranial Implants: Cadaveric Study and Clinical Findings Supporting Diagnostic and Therapeutic Transcranioplasty Ultrasound. [2023]Previously, sonographic evaluation of the intracranial contents was limited to intraoperative use following bone flap removal, with placement of the probe directly on the cortical surface or through a transsulcal tubular retractor. Cranioplasty with sonolucent implants may represent a postoperative window into the brain by allowing ultrasound to serve as a novel bedside imaging modality. The potential sonolucency of various commonly used cranial implant types was examined in this study.