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

February 5, 2026 updated by: Alejandro Rabinstein, Mayo Clinic

Early Non-invasive Detection of Progression of Mass Effect From Unilateral Brain Lesions

The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation.
  • 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.
  • Known or suspected Pregnancy
  • Adults with cranial defects or that have undergone craniectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monitoring
Imaging guided by monitoring results
Device: Non-invasive bilateral monitoring of ICP waveform
Brain4care non-invasive bilateral monitoring of ICP waveform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcome
Time Frame: 3 months
Functional outcome was assessed using the Modified Rankin Scale (mRS) which assesses functional outcomes in patients recovering from strokes. It consists of a 7-point ordinal scale ranging from 0 to 6 where 0=no symptoms and 6=dead with higher scores indicating a worse functional outcome.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging Utilization
Time Frame: within ICU admission
Number of imaging scans
within ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Alejandro Rabinstein, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Actual)

December 2, 2024

Study Completion (Actual)

December 2, 2024

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 20-009516

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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