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Non-invasive Brain Pressure Monitoring for Brain Lesions

N/A

Waitlist Available

Led By Alejandro Rabinstein, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing a new device that could measure brain pressure without needing an invasive procedure.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the Brain4Care device is non-invasive, it may have fewer side effects compared to traditional methods; however, potential discomfort or skin irritation from sensor placement might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Functional outcome

Secondary outcome measures

Imaging utilization

Trial Design

1Treatment groups

Experimental Treatment

Group I: MonitoringExperimental Treatment1 Intervention

Imaging guided by monitoring results

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,063 Total Patients Enrolled

Alejandro Rabinstein, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus, Mayo Clinic Rochester

University Nac De Cordoba (Medical School)

University Miami/Jackson Mem Mc (Residency)

2 Previous Clinical Trials

178 Total Patients Enrolled

Media Library

Hemispheric Brain Lesions Research Study Groups: Monitoring

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment process for this clinical investigation?

"As documented on clinicaltrials.gov, this medical trial is not presently accepting patients. First posted in February 2021 and last updated in February 2022, the study has yet to resume recruitment; nonetheless, 73 other trials are actively seeking participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Detect Progression of Mass Effect From Unilateral Brain Lesions

Alejandro Rabinstein 2021. "A Study to Detect Progression of Mass Effect From Unilateral Brain Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04745884.