Evidence map›Paper›PMID 40293697›Full record

ArticleNeurocritical care2025

Clinical Performance of the Brain4care System for Noninvasive Detection of Intracranial Hypertension.

Gustavo Frigieri, Thauan Leandro Gonçalves, Gabriela Nagai Ocamoto, Rodrigo de Ap Andrade, Bruno Cezar de Padua, Danilo Cardim

Registry-linked trialAbstract readEvaluation StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurocritical care, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07210333 (Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07210333 not yet recruitingnot on this map

Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System

Typeobservational_patient_registrySponsorBraincare USA CorpRan2025 to 2028Enrolled300ConditionsTraumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic, Stroke IschemicArmsnon-invasive intracranial pressure monitoring
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Impaired Intracranial Compliance: A New Hypertension-Mediated Brain Organ Damage?High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2026
    Article
  2. Article
  3. Review
  4. Observational
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Gustavo Frigieribrain4care Brazil, São Carlos, Brazil.
Thauan Leandro Gonçalvesbrain4care Brazil, São Carlos, Brazil.
Gabriela Nagai Ocamotobrain4care Brazil, São Carlos, Brazil.
Rodrigo de Ap Andradebrain4care Brazil, São Carlos, Brazil.
Bruno Cezar de Paduabrain4care Brazil, São Carlos, Brazil.
Danilo Cardimbrain4care USA, Johns Creek, GA, USA. danilo.cardim@brain4.care.ORCID 0000-0002-9261-1321

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNoninvasive methods for detecting intracranial hypertension (IH) are of growing importance in clinical settings. This study evaluates the clinical performance of the brain4care (B4C) System, which captures pulsatile cranial expansions that reveal a surrogate intracranial pressure (ICP) waveform and subsequently derives the P2/P1 ratio and time-to-peak (TTP) parameters to predict IH.

methodsThis was a retrospective study conducted across multiple centers that included a total of 124 patients. Invasively monitored ICP and noninvasive B4C waveforms were recorded simultaneously from patients with acute brain injuries. Data were analyzed using specific cutoff values for the estimated P2/P1 ratio (ranging from 0.8 to 1.4) and TTP (at 0.3) to assess their diagnostic accuracy. Sensitivity and specificity for detecting IH (ICP > 20 mm Hg) were determined based on these metrics.

resultsThe estimated P2/P1 ratio demonstrated a sensitivity of 92% and specificity of 19% at a threshold of 0.8, indicating high sensitivity for ruling out IH. At a ratio of 1.4, the specificity improved to 90%, suggesting its effectiveness for assessing IH. For TTP, a threshold of 0.3 was identified as the optimal cutoff, offering a specificity of 92%.

conclusionsThe B4C System provides a viable, noninvasive approach to assessing IH. The study underscores the clinical utility of the P2/P1 ratio and TTP in detecting and ruling out IH, offering a significant alternative to invasive ICP monitoring methods.

Indexed as

Brain Injuries, TraumaticIntracranial HypertensionIntracranial PressureNeurophysiological MonitoringAdultAgedFemaleHumansMaleMiddle AgedObservational Studies as TopicRetrospective StudiesSensitivity and SpecificityYoung AdultIntracranial complianceIntracranial hypertensionIntracranial pressureNoninvasive monitoring

Identifiers

PMID40293697
PMCPMC12436508

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.