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

Trial Summary

What is the purpose of this trial?

Postoperative rebleeding is a major limitation of surgical evacuation for intracerebral hemorrhage (ICH). While computed tomography (CT) is the standard of care for postoperative hematoma cavity monitoring, CT requires significant physical and financial costs. Studies have demonstrated varying degrees of efficacy when using transcranial ultrasound to measure ICH volume. Recently, synthetic implants for cranioplasty have been shown to be safe and sonolucent. This study aims to evaluate the ability of transcranial ultrasound with sonolucent cranioplasty (TUSC) to detect and quantify bleeding in postoperative ICH 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 data supports the effectiveness of the treatment ClearFit implant, Transcranial ultrasonography through sonolucent cranioplasty for stroke?

Research shows that sonolucent cranioplasty implants, which allow ultrasound to pass through, are safe and useful for monitoring brain conditions. Although specific data on stroke is limited, these implants have been used successfully in various brain conditions, suggesting potential benefits for stroke patients. ^{1 2 3 4 5}

Is transcranial ultrasound using sonolucent cranioplasty safe for humans?

Research on sonolucent cranioplasty, which allows ultrasound to pass through the skull, shows it is generally safe for various conditions. In studies involving 189 patients, complications were rare, including minor issues like delayed scalp healing and wound infections, affecting only a small percentage of participants. ^{1 2 3 4 6}

How is the Transcranial Ultrasound for Stroke treatment unique?

This treatment is unique because it uses a sonolucent (ultrasound-transparent) cranioplasty implant, allowing real-time ultrasound imaging of the brain through the skull. This provides a non-invasive way to monitor brain conditions and treatment effects, unlike traditional methods that may involve radiation or more invasive procedures. ^{1 2 3 6 7}

Research Team

Christopher P. Kellner, MD

Principal Investigator

Mount Sinai Health System Department of Neurosurgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sonolucent Cranial Implants: Cadaveric Study and Clinical Findings Supporting Diagnostic and Therapeutic Transcranioplasty Ultrasound. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranioplasty Ultrasonography Through a Sonolucent Prosthesis: A Review of Feasibility, Safety, and Benefits. [2023]

3. United States 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. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Neuroimaging through Sonolucent Cranioplasty: A Systematic Scoping Review Protocol. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Dural Substitutes Differentially Interfere with Imaging Quality of Sonolucent Transcranioplasty Ultrasound Assessment in Benchtop Model. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Elective Sonolucent Cranioplasty for Real-Time Ultrasound Monitoring of Flow and Patency of an Extra- to Intracranial Bypass. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Polymethyl Methacrylate Cranioplasty Is an Effective Ultrasound Window to Explore Intracranial Structures: Preliminary Experience and Future Perspectives. [2022]