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

Not Applicable

• Conditions: Non-traumatic Hemispheric Brain Lesions
• Interventions: Device: Non-invasive bilateral monitoring of ICP waveform

• Registration Number: NCT04745884
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monitoring	Non-invasive bilateral monitoring of ICP waveform	Imaging guided by monitoring results

Primary Outcome Measures

Name	Time	Method
Functional outcome	3 months	modified Rankin score

Secondary Outcome Measures

Name	Time	Method
Imaging utilization	within ICU admission	Number of imaging scans

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States