A Study to Detect Progression of Mass Effect from Unilateral Brain Lesions
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-009516
NCT ID: NCT04745884
About this study
The purposes of this study are to determine if the Braincare monitor can identify progression of mass effect from non-traumatic hemispheric brain lesions through continuous analysis of the ICP waveform and comparison of changes in ICP waveform from side to side, and to evaluate if changes in ICP curve indicative of progression of mass effect occur earlier than clinical changes that would routinely lead to repeat brain imaging.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available