Monitoring brain injury using non-invasive methods
Official title: Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
Run by Boston Medical Center · NCT06504238 · Data updated 2026-11-12
This study is trying to see if new non-invasive tests can help doctors better monitor brain injuries and spot serious problems faster in patients with conditions like traumatic brain injury and stroke.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 720 (estimated) |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | September 26, 2024 |
| Main results expected | September 2030 |
| Study ends | September 2030 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT06504238 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with a Glasgow Coma Score of less than 9 who are admitted for neuro intensive care and have evidence of intracranial pathology.
✕Probably not a fit
Patients receiving comfort measures only or those with specific injuries that preclude participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the relationship between non-invasive biomarkers and neurologic deterioration in patients with acute brain injuries, such as traumatic brain injury and ischemic stroke. It focuses on identifying life-threatening mass effects that can occur rapidly or gradually after these injuries. The study seeks to improve monitoring techniques beyond traditional methods, which often rely on subjective assessments that may delay critical interventions. By analyzing data from patients admitted under neuro intensivist care, the study hopes to enhance understanding of optimal monitoring strategies.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and earlier intervention for patients with acute brain injuries, potentially reducing morbidity and mortality.
How similar studies have gone: While there is ongoing research in non-invasive monitoring of brain injuries, this specific approach is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Comfort measure only * Any other criteria that the PI deems that makes the patient inadequate for the study * Sub-exclusion criteria for specific non-invasive measurements include: * 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
Where it's running
-
Boston Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Charlene Ong, MD MPHS — Boston Medical Center, Neurology
- Study coordinator: Charlene Ong, MD MPHS
- Email: cjong@bu.ed
- Phone: 617 638 5351
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.