Intracranial HypertensionB4C-APHNCT07747636
Non-Invasive Triage for Intracranial Hypertension in Prehospital Care
A study testing Brain4care non-invasive intracranial pressure monitor and Optic nerve sheath diameter ultrasound in people with Intracranial Hypertension and Acute Brain Injury, run by Juliana Caldas.
Trial summary
This study tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with a sudden brain injury, such as stroke or head trauma, before they reach the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypertension, Acute Brain Injury, Stroke
- What is being tested?
- Brain4care non-invasive intracranial pressure monitor and Optic nerve sheath diameter ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older
- Attended by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil
- Clinical presentation suggestive of acute stroke (sudden focal neurological deficit or sudden and severe headache) OR moderate/severe traumatic brain injury (Glasgow Coma Scale)
Who cannot join
- Individuals with brain injuries of other etiologies, such as prior traumatic brain injury (TBI) and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, and illicit drug use;
- Individuals with scalp and/or skin lacerations that prevent positioning of the brain4care sensor;
- Individuals with craniectomy;
- Severe debilitating mental health disorders and/or severe debilitating neurological diseases;
- Agitated, aggressive, or uncooperative individuals whose condition prevents follow-up and outcome assessment;
- Pregnant women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of Non-Invasive Triage for Intracranial Hypertension Assessment in Prehospital Care
This study tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with a sudden brain injury, such as stroke or head trauma, before they reach the hospital.
The tools are a wearable sensor called Brain4care, placed on the head, and an ultrasound measurement of the eye's optic nerve. Neither tool requires needles, incisions, or any invasive procedure.
Read more
The study has two parts. In the first part, researchers will use both tools on patients treated by the Mobile Emergency Care Service (SAMU) in Salvador, Brazil, to check how accurately the tools can detect high pressure inside the skull. The results from these tools will not be used to guide the patient's care during this part of the study.
In the second part, some patients will be assessed using these tools as part of their emergency care, while other patients will receive standard emergency care. Researchers will compare how often each group of patients is correctly sent to a hospital with the specialized brain surgery services they may need.
The goal of this research is to help emergency teams identify patients with dangerous brain pressure earlier and get them to the right hospital faster, which may improve their chances of recovery.
Read the detailed description
Acute brain injuries, including hemorrhagic and ischemic stroke and traumatic brain injury, are leading causes of death and disability worldwide and in Brazil. A common and dangerous complication of these injuries is intracranial hypertension (elevated pressure inside the skull), which can cause irreversible brain damage if not identified and treated promptly. Currently, there is no reliable, non-invasive method to assess intracranial pressure in the prehospital setting, which can delay referral to hospitals with neurosurgical capability.
This study evaluates two non-invasive technologies for prehospital triage: the Brain4care (B4C) device, a wearable extensometer that detects micrometric skull deformations associated with intracranial pressure fluctuations, and ultrasound measurement of the optic nerve sheath diameter (ONSD), which correlates with intracranial pressure.
The study is conducted in two sequential phases by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil.
Phase 1 is a prospective, blinded, observational proof-of-concept study in adult patients with suspected acute brain injury (stroke or moderate/severe traumatic brain injury). Both B4C and ONSD will be applied to all eligible patients, but results will not be used for clinical decision-making. Investigators interpreting reference-standard neuroimaging or invasive intracranial pressure monitoring will be blinded to the B4C and ONSD results. This phase will assess the diagnostic accuracy and operational feasibility of both methods in the prehospital environment.
Phase 2 is an open-label, randomized, controlled, parallel-group clinical trial. Eligible patients will be randomized to standard prehospital care (control group) or prehospital triage assisted by B4C and ONSD (intervention group). The primary outcome is the proportion of patients correctly referred to hospitals with neurosurgical capability. Secondary outcomes include time to neurosurgical intervention, 30-day mortality, 90-day functional outcome, length of hospital stay, adverse events, and cost-effectiveness.
This project was approved by the Research Ethics Committee of the Gonçalo Moniz Research Center - Fiocruz Bahia (CEP Opinion No. 8,050,683).
- Conditions
- Intracranial Hypertension, Acute Brain Injury, Stroke, Traumatic Brain Injury, Subarachnoid Hemorrhage
- Being tested
- Brain4care non-invasive intracranial pressure monitor, Optic nerve sheath diameter ultrasound
- Keywords
- Non-invasive intracranial pressure monitoring, Brain4care, Optic nerve sheath diameter, Prehospital triage, Emergency medical services, Neurocritical care, Intracranial pressure waveform
- Medical subject headings
- Intracranial Hypertension, Brain Injuries, Stroke, Brain Injuries, Traumatic, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain4care non-invasive intracranial pressure monitorDevice
A wearable, non-invasive sensor (FDA 510(k) cleared, K240821) placed on the scalp that detects micrometric skull deformations associated with fluctuations in intracranial pressure. The device analyzes the pulse waveform morphology to estimate intracranial compliance and infer changes in intracranial pressure, without requiring any invasive procedure. Application time is estimated at up to 5 minutes.
Optic nerve sheath diameter ultrasoundDiagnostic test
A point-of-care ultrasound measurement of the diameter of the optic nerve sheath, which correlates with intracranial pressure. Although it does not provide an absolute measurement of intracranial pressure, an enlarged optic nerve sheath diameter is a recognized bedside indicator of intracranial hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Standard Prehospital Care | No intervention | Participants receive standard prehospital assessment and care according to current SAMU protocols. Clinical and neurological evaluation and the decision to refer the patient to a hospital (with or without neurosurgical capability) are based on standard clinical and operational criteria, without use of the Brain4care device or optic nerve sheath diameter ultrasound. |
| B4C/ONSD-Assisted Triage | Experimental | In addition to standard prehospital assessment, participants are evaluated using the Brain4care (B4C) non-invasive intracranial pressure monitor and ultrasound measurement of optic nerve sheath diameter (ONSD). The decision to prioritize transport to a hospital with neurosurgical capability takes into account the results of these non-invasive assessments alongside standard clinical criteria. Receives: Device: Brain4care non-invasive intracranial pressure monitor; Diagnostic Test: Optic nerve sheath diameter ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients correctly referred to a hospital with neurosurgical capability
Proportion of patients appropriately directed to a hospital with neurosurgical support, based on imaging findings and/or the need for neurosurgical intervention, compared between the intervention (B4C/ONSD-assisted triage) and control (standard prehospital care) groups. This outcome assesses whether non-invasive triage reduces both under-referral (patients needing neurosurgery sent to centers without this capability) and over-referral (unnecessary burden on specialized centers).
Measured: From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival
Secondary outcomes (6)
Time from first medical contact to definitive neurosurgical intervention
Time elapsed between first prehospital medical contact and definitive neurosurgical intervention (when indicated), compared between patients triaged with and without the assistance of the B4C and ONSD devices.
Measured: From first prehospital contact until neurosurgical intervention, up to 30 days
30-day mortality
All-cause mortality within 30 days after the acute brain injury event, compared between patients triaged with and without the assistance of the B4C and ONSD devices.
Measured: 30 days after the acute brain injury event
Functional outcome at 90 days (modified Rankin Scale)
Functional status assessed using the modified Rankin Scale (mRS), a 7-point scale ranging from 0 (no symptoms) to 6 (death), evaluated 90 days after the acute brain injury event and compared between patients triaged with and without the assistance of the B4C and ONSD devices.
Measured: 90 days after the acute brain injury event
Length of hospital stay
Total duration of hospitalization, from admission to discharge, compared between patients triaged with and without the assistance of the B4C and ONSD devices.
Measured: From hospital admission to discharge, assessed up to 180 days
Adverse events related to use of the B4C device and ONSD ultrasound
Number and proportion of participants experiencing adverse events related to the application of the Brain4care device or optic nerve sheath diameter ultrasound during prehospital care, including minor discomfort during sensor application or any delay in care attributable to device use.
Measured: From prehospital assessment until hospital admission, assessed up to 24 hours
Cost-effectiveness of B4C/ONSD-assisted prehospital triage
Cost-effectiveness analysis of implementing B4C/ONSD-assisted triage compared to standard prehospital care, considering direct and indirect costs associated with patient care, including transport, hospitalization, and neurosurgical intervention.
Measured: From prehospital assessment through hospital discharge, assessed up to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study has two sequential phases. Phase 1 is a single-group observational proof-of-concept study (n=60) assessing the diagnostic accuracy of the B4C and ONSD methods, with no influence on clinical care. Phase 2 is a parallel-group randomized controlled trial (n=120) comparing standard prehospital care to B4C/ONSD-assisted triage.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juliana Caldas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juliana Caldas, Escola Bahiana de Medicina e Saude Publica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747636
- Sponsor's protocol ID
- 89168125.1.0000.0040
- Other IDs
- 89168125.1.0000.0040
- Acronym
- B4C-APH
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The decision on whether individual participant data (IPD) will be shared with other researchers has not yet been finalized. This will depend on institutional data governance policies, LGPD (Brazilian General Data Protection Law) compliance requirements, and further discussion among the research team regarding data anonymization, storage, and access procedures following study completion.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Non-Invasive Triage for Intracranial Hypertension Assessment in Prehospital Care
- ClinicalTrials.gov ID
- NCT07747636
- Acronym / sponsor ID
- B4C-APH / 89168125.1.0000.0040
- Conditions
- Intracranial Hypertension, Acute Brain Injury, Stroke, Traumatic Brain Injury, Subarachnoid Hemorrhage
- Keywords
- Non-invasive intracranial pressure monitoring, Brain4care, Optic nerve sheath diameter, Prehospital triage, Emergency medical services, Neurocritical care, Intracranial pressure waveform
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Juliana CaldasUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Aug 2026 (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.
This study tests whether two non-invasive tools can help paramedics detect dangerously high pressure inside the skull in patients with a sudden brain injury, such as stroke or head trauma, before they reach the hospital.
The tools are a wearable sensor called Brain4care, placed on the head, and an ultrasound measurement of the eye's optic nerve. Neither tool requires needles, incisions, or any invasive procedure.
The study has two parts. In the first part, researchers will use both tools on patients treated by the Mobile Emergency Care Service (SAMU) in Salvador, Brazil, to check how accurately the tools can detect high pressure inside the skull. The results from these tools will not be used to guide the patient's care during this part of the study.
In the second part, some patients will be assessed using these tools as part of their emergency care, while other patients will receive standard emergency care. Researchers will compare how often each group of patients is correctly sent to a hospital with the specialized brain surgery services they may need.
The goal of this research is to help emergency teams identify patients with dangerous brain pressure earlier and get them to the right hospital faster, which may improve their chances of recovery.
Detailed description
Acute brain injuries, including hemorrhagic and ischemic stroke and traumatic brain injury, are leading causes of death and disability worldwide and in Brazil. A common and dangerous complication of these injuries is intracranial hypertension (elevated pressure inside the skull), which can cause irreversible brain damage if not identified and treated promptly. Currently, there is no reliable, non-invasive method to assess intracranial pressure in the prehospital setting, which can delay referral to hospitals with neurosurgical capability.
This study evaluates two non-invasive technologies for prehospital triage: the Brain4care (B4C) device, a wearable extensometer that detects micrometric skull deformations associated with intracranial pressure fluctuations, and ultrasound measurement of the optic nerve sheath diameter (ONSD), which correlates with intracranial pressure.
The study is conducted in two sequential phases by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil.
Phase 1 is a prospective, blinded, observational proof-of-concept study in adult patients with suspected acute brain injury (stroke or moderate/severe traumatic brain injury). Both B4C and ONSD will be applied to all eligible patients, but results will not be used for clinical decision-making. Investigators interpreting reference-standard neuroimaging or invasive intracranial pressure monitoring will be blinded to the B4C and ONSD results. This phase will assess the diagnostic accuracy and operational feasibility of both methods in the prehospital environment.
Phase 2 is an open-label, randomized, controlled, parallel-group clinical trial. Eligible patients will be randomized to standard prehospital care (control group) or prehospital triage assisted by B4C and ONSD (intervention group). The primary outcome is the proportion of patients correctly referred to hospitals with neurosurgical capability. Secondary outcomes include time to neurosurgical intervention, 30-day mortality, 90-day functional outcome, length of hospital stay, adverse events, and cost-effectiveness.
This project was approved by the Research Ethics Committee of the Gonçalo Moniz Research Center - Fiocruz Bahia (CEP Opinion No. 8,050,683).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study has two sequential phases. Phase 1 is a single-group observational proof-of-concept study (n=60) assessing the diagnostic accuracy of the B4C and ONSD methods, with no influence on clinical care. Phase 2 is a parallel-group randomized controlled trial (n=120) comparing standard prehospital care to B4C/ONSD-assisted triage.
| Arm | Type | Receives |
|---|---|---|
| Standard Prehospital Care | No intervention | –Participants receive standard prehospital assessment and care according to current SAMU protocols. Clinical and neurological evaluation and the decision to refer the patient to a hospital (with or without neurosurgical capability) are based on standard clinical and operational criteria, without use of the Brain4care device or optic nerve sheath diameter ultrasound. |
| B4C/ONSD-Assisted Triage | Experimental | Device: Brain4care non-invasive intracranial pressure monitor, Diagnostic Test: Optic nerve sheath diameter ultrasoundIn addition to standard prehospital assessment, participants are evaluated using the Brain4care (B4C) non-invasive intracranial pressure monitor and ultrasound measurement of optic nerve sheath diameter (ONSD). The decision to prioritize transport to a hospital with neurosurgical capability takes into account the results of these non-invasive assessments alongside standard clinical criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Attended by the Mobile Emergency Care Service (SAMU) in the metropolitan area of Salvador, Brazil
- Clinical presentation suggestive of acute stroke (sudden focal neurological deficit or sudden and severe headache) OR moderate/severe traumatic brain injury (Glasgow Coma Scale)
Key exclusion criteria (6 listed)
- Individuals with brain injuries of other etiologies, such as prior traumatic brain injury (TBI) and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, and illicit drug use;
- Individuals with scalp and/or skin lacerations that prevent positioning of the brain4care sensor;
- Individuals with craniectomy;
- Severe debilitating mental health disorders and/or severe debilitating neurological diseases;
- Agitated, aggressive, or uncooperative individuals whose condition prevents follow-up and outcome assessment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain4care non-invasive intracranial pressure monitorA wearable, non-invasive sensor (FDA 510(k) cleared, K240821) placed on the scalp that detects micrometric skull deformations associated with fluctuations in intracranial pressure. The device analyzes the pulse waveform morphology to estimate intracranial compliance and infer changes in intracranial pressure, without requiring any invasive procedure. Application time is estimated at up to 5 minutes. | Device | B4C/ONSD-Assisted Triage |
| Optic nerve sheath diameter ultrasoundA point-of-care ultrasound measurement of the diameter of the optic nerve sheath, which correlates with intracranial pressure. Although it does not provide an absolute measurement of intracranial pressure, an enlarged optic nerve sheath diameter is a recognized bedside indicator of intracranial hypertension. | Diagnostic test | B4C/ONSD-Assisted Triage |
Primary outcome
Proportion of patients correctly referred to a hospital with neurosurgical capability
Time frame: From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival
Proportion of patients appropriately directed to a hospital with neurosurgical support, based on imaging findings and/or the need for neurosurgical intervention, compared between the intervention (B4C/ONSD-assisted triage) and control (standard prehospital care) groups. This outcome assesses whether non-invasive triage reduces both under-referral (patients needing neurosurgery sent to centers without this capability) and over-referral (unnecessary burden on specialized centers).
6 secondary outcomes
Time from first medical contact to definitive neurosurgical intervention
Time frame: From first prehospital contact until neurosurgical intervention, up to 30 days
30-day mortality
Time frame: 30 days after the acute brain injury event
Functional outcome at 90 days (modified Rankin Scale)
Time frame: 90 days after the acute brain injury event
Length of hospital stay
Time frame: From hospital admission to discharge, assessed up to 180 days
Adverse events related to use of the B4C device and ONSD ultrasound
Time frame: From prehospital assessment until hospital admission, assessed up to 24 hours
Cost-effectiveness of B4C/ONSD-assisted prehospital triage
Time frame: From prehospital assessment through hospital discharge, assessed up to 180 days
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 5 Aug 2026.
- Individual participant dataSharing planned: Undecided. The decision on whether individual participant data (IPD) will be shared with other researchers has not yet been finalized. This will depend on institutional data governance policies, LGPD (Brazilian General Data Protection Law) compliance requirements, and further discussion among the research team regarding data anonymization, storage, and access procedures following study completion.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Brain4care non-invasive intracranial pressure monitor and Optic nerve sheath diameter ultrasound in people with Intracranial Hypertension and Acute Brain Injury, run by Juliana Caldas.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Davi J Fontoura Solla, PhD (+55 71 9978-1989, davisolla@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients correctly referred to a hospital with neurosurgical capability (time frame: From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival). 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 5 Aug 2026.