Brain Injury, AcuteNIMABINCT06504238
Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
An observational study of Brain Injury, Acute, run by Boston Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Acute
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to Sep 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Charlene Ong, MD MPHS, cjong@bu.ed
Leigh Mallinger, BA, 617-638-7732, leigh.mallinger@bmc.org
About this study
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
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Secondary outcomes (2)
Number of participant deaths during hospitalization
This data will be abstracted from medical records..
Measured: 5 years
Functional outcome at hospital discharge
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start26 Sep 2024
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlene Ong, MD MPHS, Principal investigator, Boston Medical Center, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504238
- Sponsor's protocol ID
- H-44955
- Acronym
- NIMABI
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No