Non-invasive Brain Pressure Monitoring for Brain Lesions

Overseen By Amy Headlee, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Unable to consent

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Brain4Care device, which measures brain pressure without surgery. The research focuses on ensuring the device's safety and effectiveness for individuals with specific brain lesions that might worsen. It targets adults in a neuroscience ICU who face serious brain pressure changes and are not immediately scheduled for surgery. Participants must be able to consent to the trial themselves or have someone provide consent for them. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance brain pressure monitoring for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Brain4Care device is safe for measuring intracranial pressure?

Research has shown that the Brain4Care device is safe for use. It is non-invasive, operating without entering the body. The device measures intracranial pressure with a small pin that rests on the head.

Studies have found that this method avoids the risks associated with more invasive procedures, such as surgery. The device has been used in various situations, and reports of negative side effects are rare. The FDA has approved it for monitoring intracranial pressure, further confirming its safety.

Overall, previous tests have shown that the Brain4Care device is well-received, with few to no negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brain4Care device because it offers a non-invasive way to monitor brain pressure in patients with brain lesions. Unlike traditional methods that might require invasive procedures like intracranial pressure monitoring, this device uses advanced imaging guided by the monitoring results, reducing the need for surgical intervention. This approach could lead to faster, safer, and more comfortable assessments for patients, potentially transforming how brain pressure is managed and improving outcomes.

What evidence suggests that the Brain4Care device is effective for measuring intracranial pressure?

Research has shown that the Brain4Care device, used by participants in this trial, is promising for non-surgical monitoring of intracranial pressure. Studies have found it accurately tracks changes in brain pressure, crucial for managing brain injuries. One study noted that this device could assist doctors in making better decisions by providing continuous pressure readings. The technology detects small changes in the skull, and early findings suggest it could reliably replace more invasive methods. Overall, the Brain4Care device holds potential as a safer way to monitor brain pressure. ^{5 6 7 8 9}

Who Is on the Research Team?

Alejandro Rabinstein, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with non-traumatic brain lesions at risk of increased pressure and herniation, who are in the Neuroscience ICU for monitoring. They should not be scheduled for immediate surgery. It's not open to minors or those unable to consent without a surrogate.

Inclusion Criteria

You are an adult with a brain lesion that could cause swelling and potentially lead to dangerous brain shifts.

Patients admitted the Neuroscience ICU for serial neurological monitoring

Patients whose care is not expected to include immediate surgical decompression

Exclusion Criteria

Patients under the age of 18

Patients who are unable to provide consent due to neurologic deficit and does not have a surrogate decision maker available to provide consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monitoring

Participants are monitored using the Brain4Care device to measure intracranial pressure

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain4Care device

Trial Overview The study tests the Brain4Care device's ability to measure intracranial pressure (ICP) safely and effectively without invasive methods, which could help monitor patients' conditions more comfortably.

How Is the Trial Designed?

Group I: Monitoring Experimental Treatment 1 Intervention

Imaging guided by monitoring results

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12436508/

Clinical Performance of the Brain4care System for ... This study aims to evaluate the feasibility and clinical performance of a novel noninvasive device for intracranial dynamics monitoring capable of deriving such ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07210333

Non-invasive Intracranial Pressure Monitoring to Improve ... The study aims to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) monitoring, ...

3. brain4.care brain4.care/wp-content/uploads/2022/01/A-Nanometer-Resolution-Wearable-Wireless-Medical-Device-for-Non-Invasive-Intracranial-Pressure-Monitoring.pdf

A-Nanometer-Resolution-Wearable-Wireless-Medical- ... Abstract—The non-invasive intracranial pressure (NIICP) method based on a skull deformation has been proven to be a significant tool for an assessment of the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0952818025002387

Non-invasive intracranial pressure assessment in adult ... The authors concluded that automated pupillometry rule out ICH patients without IH, facilitating clinical management by saving invasive ICP monitoring or ...

5. nature.com nature.com/articles/s41746-025-01463-y

Machine learning approach for noninvasive intracranial ... This observational study developed and tested a machine learning (ML) model to estimate ICP using waveforms from a cranial extensometer device.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240821.pdf

B4C System with BcSs-PICNIW-2000 sensor model The B4C System is a non-invasive device intended for monitoring of variation in intracranial pressure including patients with suspected ...

7. brain4.care brain4.care/en/

non-invasive intracranial dynamics monitoring brain4care monitors intracranial dynamics, including variation of intracranial pressure (ICP), progression of intracranial compliance and early assessment of ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07113353

NCT07113353 | Non-Invasive ICP Monitoring Study This monitor has a tiny pin that is placed on the head which measures the tiny movements of the skull every time the heart beats. This produces ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K201989.pdf

October 8, 2021 Braincare Desenvolvimento e Inovacao ... The B4C System is a non-invasive device intended for the monitoring of variation in intracranial pressure, including patients with suspected ...