Recruiting

Observational Study

Sponsor:

Boston Medical Center

Code:

NCT06504238

Conditions

Brain Injury, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06504238

Start date

Sep 26, 2024

Status verified date

Sep, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

720 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Primary outcome measure

  • Neurologic Deterioration [ Time Frame: 5 years ]
  • Glasgow Coma Scores [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Charlene Ong, MD MPHS

617 638 5351cjong@bu.ed

Leigh Mallinger, BA

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

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Charlene Ong, MD MPHS

cjong@bu.ed

Leigh Mallinger, BA

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

More Information

Sponsor

Boston Medical Center

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.