Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

NCT06504238 | Recruiting

• 1 other identifier: H-44955
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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

Brain Injury, Acute

Keywords

Life-threatening mass effect (LIME); Traumatic brain injury (TBI); Ischemic stroke (IS); Intraparenchymal hemorrhage (IPH); Neurologic deterioration; Intracranial Pressure (ICP); Glasgow Coma Scores

Outcome Measures

Primary Outcomes (2)

• Neurologic Deterioration

  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.

  5 years

• Glasgow Coma Scores

  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.

  5 years

Secondary Outcomes (2)

• Number of participant deaths during hospitalization

  5 years

• Functional outcome at hospital discharge

  5 years

Study Arms (1)

NIMABI Group

Eligible patients will be recruited on admission to the ICU followed by the Neurointensive care team. Demographic, invasive ICP monitoring data, clinical, laboratory, diagnostic, treatment (medical and surgical) and outcome data will be collected. Data will be collected from non-invasive devices using either clinical review from the chart, or if not available and/or used for additional measurements, from the device (smartguard for pupillometry, imaging, EEG data, Brain4care data).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be recruited on admission to the intensive care unit (ICU) at Boston Medica Center followed by the Neurointensive care team.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators are building a repository of demographic, invasive ICP monitoring data, clinical, laboratory, diagnostic, treatment (medical and surgical) and outcome data will be collected (variables below). Data will be collected from non-invasive devices using either clinical review from the chart, or if not available and/or used for additional measurements, from the device (smartguard for pupillometry, imaging, EEG data, Brain4care data). The limited dataset (the only identifiers being dates of pupil measurements/medical services) will be maintained in a password secured and HIPAA protected REDCap database.

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Ischemic Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stroke; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charlene Ong, MD MPHS

  Boston Medical Center, Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlene Ong, MD MPHS

CONTACT

617 638 5351; cjong@bu.ed

Leigh Mallinger, BA

CONTACT

617-638-7732; leigh.mallinger@bmc.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)