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

Mayo Clinic6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Non-traumatic Hemispheric Brain Lesions

Interventions

Non-invasive bilateral monitoring of ICP waveformDEVICE

Brain4care non-invasive bilateral monitoring of ICP waveform

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Functional Outcome

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.

Time frame: 3 months

Secondary Outcomes

Imaging Utilization

Number of imaging scans

Time frame: within ICU admission

Data from ClinicalTrials.gov

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