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Study identifier: NCT06504238 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

Condition: Brain Injury, Acute  ·  Sponsor: Boston Medical Center

PhaseN/A
Planned participants720
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Life-threatening mass effect (LTME) arises when brain swelling displaces or compresses crucial midline structures subsequent to acute brain injuries (ABIs) like traumatic brain injury (TBI), ischemic stroke (IS), and intraparenchymal hemorrhage (IPH), which can manifest rapidly within hours or more gradually over days. Despite advancements in surgical management, significant gaps in understanding persist regarding optimal monitoring and therapeutic approaches. The current standard for identifying LTME involves neurologic decline in conjunction with radiographic evidence or increased intracranial pressure (ICP) indicating space-occupying mass effect. However, in critically ill patients, reliance on subjective physical exam findings, such as decreased arousal, often leads to delayed recognition, occurring only after catastrophic shifts have already occurred. The goal of this study is to determine the association of non-invasive biomarkers with neurologic deterioration, and to determine whether non-invasive biomarker inclusion improves detection of outcome and decline. The investigators propose to use various non-invasive methods to monitor ICP as adjuncts in detecting deteriorating mass effect. These methods include quantitative pupillometry, radiographic data, laboratory data, and other bedside diagnostic tests available including electroencephalography (EEG), skull vibrations detected via brain4care device, optic nerve sheath diameter assessment (ONSD), and ultrasound-guide…

This description comes directly from the study's public registry record.

Talk to the study team

Charlene Ong, MD MPHS  ·  617 638 5351  ·  cjong@bu.ed

Leigh Mallinger, BA  ·  617-638-7732  ·  leigh.mallinger@bmc.org

Always discuss trial participation with your own doctor first.

Locations (1)

Boston Medical CenterBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06504238