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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-04

Study Completion Date

2024-12-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-traumatic Hemispheric Brain Lesions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Monitoring

Imaging guided by monitoring results

Group Type EXPERIMENTAL

Non-invasive bilateral monitoring of ICP waveform

Intervention Type DEVICE

Brain4care non-invasive bilateral monitoring of ICP waveform

Interventions

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Non-invasive bilateral monitoring of ICP waveform

Brain4care non-invasive bilateral monitoring of ICP waveform

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No