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Non-Invasive Monitoring for Acute Brain Injury

This study is looking at different ways to monitor patients with acute brain injuries (ABIs) like traumatic brain injury or stroke. These injuries can cause brain swelling, called life-threatening mass effect (LTME), which can be very serious. Researchers want to understand the best ways to detect LTME early and improve care. This is an observational study, meaning you would be monitored as part of your regular care, not given a new treatment. The study aims to enroll 720 adults (18 years and older) who are admitted under a neuro intensivist and have a head CT scan showing an intracranial (inside the skull) problem that could lead to LTME. Success will be measured by tracking neurologic deterioration (worsening brain function) and Glasgow Coma Scores (a measure of consciousness) over 5 years.

Study design
This is an observational study, meaning researchers will gather information about your care without providing a specific intervention. It plans to include 720 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to track neurologic deterioration and Glasgow Coma Scores.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06504238

Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

Recruiting
Not specifiedAges 18+Observational
Boston Medical Center
~720 participants
Updated 2025-10-29 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurologic Deterioration
Measured over 5 years
+1 more outcome measured

Conditions

Brain Injury, Acute

Explore related trials

Brain InjuryIntraparenchymal hemorrhage of brainIschemic StrokeTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Charlene Ong, MD MPHS · PRINCIPAL_INVESTIGATOR · Boston Medical Center, Neurology

Who to contact

Charlene Ong, MD MPHS
[email protected]
617 638 5351
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Admitted under Neuro intensivist primary or consultative care.
At least one head computed tomography (CT) scan demonstrating intracranial pathology that may lead to life-threatening mass effect (i.e. traumatic brain injury, ischemic or hemorrhagic stroke, epidural or subdural hematoma, subarachnoid hemorrhage, diffuse hypoxic injury, metabolic cerebral edema, tumor)
Concern for Life Threatening Mass Effect
Glasgow Coma Score (GCS) \<9
Anticipated stay \>24 hours

Exclusion

Comfort measure only
Any other criteria that the PI deems that makes the patient inadequate for the study
Orbital injury (pupillometry, ONSD)
Traumatic injury or surgery that precludes use of B4C device
Presence of supratentorial craniectomy or craniotomy that has not healed and is mobile/bone defects/scalp injury \[EEGelectroencephalogram (EEG), Brain4Care\]
Presence of extensive scalp injury

What this trial measures

  • Neurologic Deterioration5 years

    Neurologic deterioration will be assessed as a dichotomous variable (yes/no) defined as a negative change in any of the following: level of consciousness, agaze, arm motor function, leg motor function, or language. The participants' medical chart will be reviewed for documentation of persistent change.

  • Glasgow Coma Scores5 years

    The Glasgow Coma Scale (GCS) is a 15-point scale used to evaluate a person's state of consciousness. A score of 3 is the lowest possible and indicates a deep coma or death, while a score of 15 is the highest and indicates a fully awake person. A lower score generally means a deeper coma.