Monitoring brain injury using non-invasive methods
Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
Boston Medical Center · NCT06504238
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 |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06504238 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients receiving comfort measures only or those with specific injuries that preclude participation may not benefit from this study.
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 performed: While there is ongoing research in non-invasive monitoring of brain injuries, this specific approach is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Injury, Acute, Life-threatening mass effect, Traumatic brain injury, Ischemic stroke, Intraparenchymal hemorrhage, Neurologic deterioration, Intracranial Pressure, Glasgow Coma Scores