An interventional study of Brain4care non-invasive intracranial pressure monitor and Optic nerve sheath diameter ultrasound in Intracranial Hypertension, Acute Brain Injury and Stroke, sponsored by Juliana Caldas. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Juliana Caldas · Not applicable, Interventional, and Diagnostic
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.
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).
165 studies on the registry are indexed under Intracranial Hypertension; 36 are open to participants now.
This study's planned enrollment of 180 is above the median of 50 across 81 interventional studies indexed under Intracranial Hypertension.
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Exclusion Criteria:
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.
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.
Device: Brain4care non-invasive intracranial pressure monitor · Diagnostic Test: Optic nerve sheath diameter ultrasound
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.
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.
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).
Time frame: From prehospital assessment (Phase 2) up to hospital admission and determination of neurosurgical need, assessed within 24 hours of hospital arrival
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From prehospital assessment through hospital discharge, assessed up to 180 days
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2027, 4 months later.
Of 37 non-industry interventional studies with no phase under Intracranial Hypertension, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 39. This study's planned 4 months is below that.
Counting every sponsor, half of 38 studies reached it within 18 months; a quarter within 6 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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