Transcranial Ultrasound for Stroke

(TUSC MIS Trial)

Overseen By Javin S Bose

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Anticoagulants

Disqualifiers: Vascular malformation, Skull neoplasm, Coagulopathy, Active infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect bleeding after brain surgery for intracerebral hemorrhage. Instead of using a CT scan, which can be costly and requires patient movement, the study employs ultrasound technology with a special implant (ClearFit implant) to view inside the skull. The researchers aim to determine if this method effectively identifies and measures bleeding. Individuals who have experienced a stroke with brain bleeding, are undergoing surgery with a special implant, and have significant daily life impacts might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance post-surgery care for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using certain blood thinners at the time of the stroke. It's best to discuss your specific medications with the trial team.

What prior data suggests that transcranial ultrasound with sonolucent cranioplasty is safe for detecting and quantifying bleeding in postoperative ICH patients?

Research has shown that transcranial ultrasound with a special type of skull repair is safe for patients. Studies have found this method practical, especially for those recovering from brain surgeries such as brain bleeding. Recent findings report no serious side effects, indicating that patients generally tolerate it well. The material used for skull repair is also safe, providing extra reassurance. This technique enables doctors to monitor the brain effectively without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of transcranial ultrasonography through sonolucent cranioplasty for stroke treatment because it represents a novel approach that could enhance recovery. Unlike traditional treatments like clot-busting drugs or mechanical thrombectomy, this method uses sound waves to potentially improve brain healing. The unique aspect is the sonolucent cranioplasty, which allows ultrasound waves to penetrate the skull more effectively, potentially enhancing the precision and effectiveness of the treatment. This new method could offer a non-invasive alternative that improves outcomes for stroke patients.

What evidence suggests that transcranial ultrasonography through sonolucent cranioplasty is effective for detecting and quantifying bleeding in postoperative ICH patients?

Research has shown that using ultrasound through a special type of skull implant, which participants in this trial may receive, promises to detect and measure bleeding in patients after brain surgery. Early results suggest it is safe and practical, with no major safety issues reported. This noninvasive method effectively checks changes in brain blood flow, aiding in predicting recovery after surgery. Although the data remains new and varied, early experiences indicate potential benefits in monitoring patients with brain bleeding. This method could offer a more cost-effective option compared to traditional imaging like CT scans. ^{2 3 4 6 7}

Who Is on the Research Team?

Christopher P. Kellner, MD

Principal Investigator

Mount Sinai Health System Department of Neurosurgery

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a stroke leading to bleeding in the brain, are undergoing a specific minimally invasive surgery with sonolucent cranioplasty, and have certain scores on stroke severity scales. Excluded are those with skull fractures, other causes of bleeding, coagulation issues, active infections or substance abuse problems.

Inclusion Criteria

I am having a surgery to remove a brain bleed using a special technique.

Your National Institute of Health Stroke Scale (NIHSS) score is 6 or higher.

I have had a significant brain bleed above the cerebellum.

Exclusion Criteria

You have another health condition that may make it hard for you to stay healthy for the duration of the study.

My brain bleed is due to a specific underlying condition like an aneurysm or tumor.

I have a bleeding disorder or am on blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Postoperative ICH patients undergo cranioplasty with a sonolucent polymethyl methacrylate implant and serial monitoring via TUSC

6 months

Regular monitoring visits aligned with CT scans

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the assessment of serious adverse events and cost of care

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ClearFit implant
• Transcranial ultrasonography through sonolucent cranioplasty

Trial Overview The study tests if transcranial ultrasound through a transparent implant can effectively monitor post-surgery bleeding in the brain. It compares this method's ability to detect and measure blood against standard CT scans which are more costly and physically demanding.

How Is the Trial Designed?

Group I: transcranial ultrasonography through sonolucent cranioplasty Experimental Treatment 2 Interventions

All surgical procedures and implants in this protocol are standard of care.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

The study found that different dural substitutes (DSs) used during transcranioplasty ultrasound (TCUS) can affect imaging quality, with DuraGen and Durepair providing comparable Doppler quality to the control, while DuraMatrix-Onlay and DuraMatrix Suturable performed worse.

These findings were based on a benchtop model using a ClearFit implant and require further clinical validation to confirm their relevance in actual medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dural Substitutes Differentially Interfere with Imaging Quality of Sonolucent Transcranioplasty Ultrasound Assessment in Benchtop Model. Flores, AR., Srinivasan, VM., Gadot, R., et al.[2021]

Transcranial sonography (TCS) using polymethylmethacrylate cranioplasties (PMMA-CP) as a sonic window provided high-quality images of intracranial structures in a study of 6 patients, demonstrating its potential as a reliable imaging technique.

The study suggests that TCS could reduce the need for follow-up CT and MRI scans in patients with PMMA-CP, although the effectiveness was somewhat limited by the curvature of the cranial flap affecting probe adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polymethyl Methacrylate Cranioplasty Is an Effective Ultrasound Window to Explore Intracranial Structures: Preliminary Experience and Future Perspectives. Spena, G., Guerrini, F., Grimod, G., et al.[2022]

Sonolucent cranioplasty (SC) implants are emerging as a safe and effective option for repairing skull defects, offering unique advantages such as the ability to monitor brain anatomy and hemodynamics post-surgery.

Current research includes various studies on SC, including cadaveric studies and patient safety assessments, indicating a growing interest in its applications for enhanced neurosurgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging through Sonolucent Cranioplasty: A Systematic Scoping Review Protocol. Rossitto, CP., Devarajan, A., Price, G., et al.[2022]

The use of a sonolucent PMMA cranioplasty implant after EC-IC bypass surgery allows for real-time ultrasound monitoring of bypass flow and patency, overcoming limitations of traditional imaging methods.

This technique was successfully demonstrated in a moyamoya patient, where immediate postoperative ultrasound confirmed bypass patency and flow measurements, providing a less invasive alternative to standard imaging methods like CTA and catheter angiogram.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elective Sonolucent Cranioplasty for Real-Time Ultrasound Monitoring of Flow and Patency of an Extra- to Intracranial Bypass. Hadley, C., North, R., Srinivasan, V., et al.[2022]

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]

The study demonstrated that elective sonolucent cranioplasty using a PMMA implant during EC-IC bypass surgery is safe, with no complications related to the bypass or the implant in all 7 patients studied.

Transcranioplasty ultrasound (TCUS) was successfully used to monitor bypass patency post-surgery, and patients reported high satisfaction with the cosmetic results and overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Feasibility, and Patient-Rated Outcome of Sonolucent Cranioplasty in Extracranial-Intracranial Bypass Surgery to Allow for Transcranioplasty Ultrasound Assessment. Flores, AR., Srinivasan, VM., Seeley, J., et al.[2021]

This systematic review analyzed 16 studies involving 189 patients using sonolucent cranioplasty (SC) for neuroimaging, indicating its application in various conditions like hydrocephalus and tumors, with a majority of patients being female and aged from teens to 80s.

Complications from SC were relatively low, with only 3% experiencing wound infections and 3% having delayed scalp healing, suggesting that SC is a safe option for neuroimaging, though future studies should focus on collecting quantitative data to improve imaging validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranioplasty Ultrasonography Through a Sonolucent Prosthesis: A Review of Feasibility, Safety, and Benefits. Rossitto, CP., Devarajan, A., Zhang, JY., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875023009208

Transcranioplasty Ultrasonography Through a Sonolucent ... Data on the effectiveness of transcranioplasty ultrasonography through sonolucent cranioplasty (SC) are new and heterogeneous. We performed the first systematic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05538286

Transcranial Ultrasound Via Sonolucent Cranioplasty After ... This study aims to evaluate the ability of transcranial ultrasound with sonolucent cranioplasty (TUSC) to detect and quantify bleeding in postoperative ICH ...

3. jnis.bmj.com jnis.bmj.com/content/15/Suppl_1/A108.2

E-056 Initial experience with transcranial ultrasound ... Conclusion Transcranial ultrasound through sonolucent cranioplasty is safe and feasible in postoperative intracerebral hemorrhage patients. There were no ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37422186/

A Review of Feasibility, Safety, and Benefits Data on the effectiveness of transcranioplasty ultrasonography through sonolucent cranioplasty (SC) are new and heterogeneous.

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

Transcranial Ultrasound for Cranioplasty This method is noninvasive and has been useful in assessing improvements in brain blood flow and predicting clinical outcomes after surgery.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7438362/

Safety, Feasibility, and Patient-Rated Outcome of Sonolucent ... In this study we were able to show that this novel technique is safe, allows for patency assessment of the EC-IC bypass using bedside TCUS technique, and is ...

7. jnis.bmj.com jnis.bmj.com/content/15/Suppl_1/A70.2

P-023 Initial experience with transcranial ultrasound ... Conclusion Transcranial ultrasound through large, customized sonolucent cranioplasty is safe and feasible after decompressive hemicraniectomy. This imaging ...