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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Monitoring Methods in Patients With Acute Brain Injury
- ClinicalTrials.gov ID
- NCT06504238
- Acronym / sponsor ID
- NIMABI / H-44955
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Number of participant deaths during hospitalization
Time frame: 5 years
Functional outcome at hospital discharge
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlene Ong, MD MPHS principal investigator
Boston Medical Center, Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury, Acute, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlene Ong, MD MPHS (617 638 5351, cjong@bu.ed), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic Deterioration (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.