TerminatedNot Applicable

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

Stopped: Device sensitive issues

United States6 participantsStarted 2021-02-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Functional Outcome

Timeframe: 3 months

Trial details

NCT IDNCT04745884

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-02

Results submitted2025-11-13

View on ClinicalTrials.gov More Non-traumatic Hemispheric Brain Lesions trials