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NCT Number: NCT06504238

Non-Invasive Monitoring Methods in Patients With Acute Brain Injury

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.

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Key information

Conditions

Brain Injury, Acute Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Ischemic Stroke Nervous System Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neurologic Deterioration

    Time frame: 5 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.

  2. Glasgow Coma Scores

    Time frame: 5 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.

Secondary outcomes

  1. Number of participant deaths during hospitalization

    Time frame: 5 years

    This data will be abstracted from medical records..

  2. Functional outcome at hospital discharge

    Time frame: 5 years

    This will be assessed by Modified Rankin Scale (mRS), a 6 point disability scale with possible scores ranging from 0 to 5, higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. A separate category of 6 is usually added for patients who expire. Data will be abstracted from medical records on review of patient notes and discharge summaries to obtain amRS for each participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Charlene Ong, MD MPHS

CONTACT

[email protected]

617 638 5351

Leigh Mallinger, BA

CONTACT

[email protected]

617-638-7732

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Acronym: NIMABI

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jul 16, 2024
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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