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Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
NCT06504238 · View on ClinicalTrials.gov ↗
Study Summary
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-guided eyeball compression. Some of these methods will be measured \*only\* for the purposes of the research study (such as skull vibrations via brain4care). Other measurements, such as quantitative pupillometry, will represent additional measurements beyond those already being collected for clinical care. This research study is necessary to understand the association of these non-invasive biomarkers with neurological decline and outcomes while considering potential confounding factors.
Conditions Studied
Study Locations (1)
Massachusetts
- Boston Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2024-09-26 |
| Est. Completion | 2030-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06504238
The ClinicalTrials.gov registry entry for NCT06504238 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 192 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Brain Injury, Acute appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06504238 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06504238 about?
NCT06504238 is a clinical study titled "Non-Invasive Monitoring Methods in Patients With Acute Brain Injury". 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 ...
What is the current status of trial NCT06504238?
This trial is currently recruiting. The enrollment target is 720 participants. The study started on 2024-09-26. Estimated completion is 2030-09.
What conditions does trial NCT06504238 study?
This clinical trial studies the following conditions: Brain Injury, Acute. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT06504238?
This trial is sponsored by Boston Medical Center, which has 192 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06504238 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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