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

Mayo Clinic

Status: Completed

Conditions: Non-traumatic Hemispheric Brain Lesions

Treatments: Device: Non-invasive bilateral monitoring of ICP waveform

Study type: Interventional

Funder types: Other

Identifiers

NCT04745884

20-009516

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Monitoring

Experimental group

Description:

Imaging guided by monitoring results

Treatment:

Device: Non-invasive bilateral monitoring of ICP waveform