Traumatic Brain Injury (TBI) PatientsNCT07210333
Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
An observational study of Traumatic Brain Injury (TBI) Patients and Stroke Hemorrhagic, run by Braincare USA Corp at 3 sites in Brazil.
Trial summary
The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2/P1 ratio and nTTP) obtained with the brain4care system for the screening of intracranial hypertension… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic, Stroke Ischemic
- What is being tested?
- non-invasive intracranial pressure monitoring
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 3 sitesBrazil
- Study dates
- 16 Dec 2025to 28 Jan 2028
- How long will I take part?
- 14 Days
- 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: Adult patients (≥18 years) of both sexes presenting with clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic). Participants will be recruited from multiple levels of care within the Brazilian Unified Health System (SUS), including primary care units (UBS), urgent care units (UPA), pre-hospital emergency services (SAMU), hospital emergency rooms (PS), and intensive care units (ICUs) at participating hospitals in the states of Amazonas, São Paulo, Sergipe, and Rio Grande do Sul.
Who may be able to join
- Patients of both sexes.
- Age ≥ 18 years.
- Clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic).
- Signed informed consent form by the patient or by a legally authorized representative in cases where the patient is unable to consent due to the severity of the clinical condition. If the legal representative is not present at the time of admission or initial care, consent may be obtained retrospectively.
Who cannot join
- Individuals with brain lesions of other etiologies, such as previous TBI and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, or illicit drug use.
- Individuals with scalp or skin lacerations that prevent proper placement of the brain4care sensor.
- Individuals with craniectomy or skull fractures.
- Individuals with severe debilitating mental health disorders and/or severe debilitating neurological diseases.
- Individuals who are agitated, aggressive, or uncooperative, preventing follow-up and outcome assessment.
- Pregnant women.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil3 sites
Hospital Universitário de Lagarto
Lagarto, Sergipe, 49400-000
Study Principal Investigator, + 55 (79) 9671-0130, ritavieira@academico.ufs.br
Rita C Almeida Vieira, PhD
Hospital Universitário Getúlio Vargas
Manaus, Amazonas, 69020-170
Study Principal Investigator, + 55 (92) 9403-4101, amorim.robson@gmail.com
Robson L Oliveira de Amorim, PhD
Hospital São Paulo
São Paulo, São Paulo, 04024-002
Study Principal Investigator, +55 (11) 98267-7217, drfabiano.neurologia@gmail.com
Fabiano Moulin de Moraes, PhD
About this study
Official title: Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System
The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2/P1 ratio and nTTP) obtained with the brain4care system for the screening of intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke treated in Brazil's public health system (SUS).
The main questions it aims to answer are:
Read more
Can non-invasive ICP and ICC pulse morphology reliably identify or exclude intracranial hypertension, cerebral edema, and hemorrhage compared to CT findings and clinical/neurological evaluations?
Can this approach differentiate ischemic stroke from hemorrhagic stroke with sufficient accuracy?
Does the use of brain4care contribute to earlier detection, improved clinical decision-making, and cost reduction in emergency settings?
Read the detailed description
This is a prospective, observational, multicenter, longitudinal cohort study conducted in four Brazilian states (Amazonas, São Paulo, Sergipe, and Rio Grande do Sul). The study aims to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) monitoring, using the brain4care system, for screening intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke (ischemic or hemorrhagic) admitted to multiple levels of care in the Brazilian Unified Health System (SUS), including pre-hospital care (SAMU), primary care (UBS), urgent care units (UPA), emergency rooms (PS), and intensive care units (ICUs).
Study Procedures
Eligible participants (≥18 years) with TBI or stroke will undergo daily non-invasive ICP and ICC monitoring using the BWS 2.0 (Braincare Wireless System). Monitoring will be performed by trained medical and nursing teams, adjusted according to care setting:
SAMU (pre-hospital): 5 minutes of valid pulses during stabilization and transport.
UBS, UPA, and PS: 10 minutes of valid pulses during initial evaluation; repeated daily until transfer.
ICU: three times daily (every 8 hours) for 10 minutes during the first 72h, then twice daily (every 12 hours) for up to 14 days, each session lasting 30 minutes.
Clinical data include demographics, comorbidities, neurological exam findings (Glasgow Coma Scale, Cincinnati Stroke Scale, NIHSS, Hunt-Hess, WFNS, Rankin), and vital signs. Neuroimaging will be collected when available, with application of validated CT-based scales (Marshall, Rotterdam, ASPECTS, Fisher, STICH, CRASH).
Technology
The BWS 2.0 sensor applies piezoelectric technology to detect minute cranial deformations linked to ICP waveforms, allowing calculation of morphological parameters such as P2/P1 ratio and normalized Time-to-Peak (nTTP). Changes in these parameters reflect alterations in intracranial compliance, providing a non-invasive tool to identify or exclude ICH.
Data Collection and Quality Assurance
All data will be recorded in REDCap, a secure, validated data capture system. A data dictionary describes all study variables, coding conventions (e.g., MedDRA for clinical events), and reference ranges. Automated range and consistency checks will be applied during data entry. Source data verification will be performed by comparing REDCap records with hospital charts, imaging reports, and device outputs.
Site monitoring will ensure adherence to standard operating procedures (SOPs) for patient recruitment, informed consent, device handling, data collection, and reporting of adverse events. Periodic audits and central data review will reinforce data integrity.
Sample Size and Analysis
An initial sample of 300 patients was calculated to provide sufficient power for ROC curve analysis. The primary outcome is diagnostic performance (AUC, sensitivity, specificity, predictive values) of brain4care parameters against reference standards (CT and clinical scales). Secondary analyses include correlation with clinical and imaging findings, differentiation of ischemic vs. hemorrhagic stroke, and evaluation of cases with hemorrhagic transformation.
Statistical methods include parametric or non-parametric tests (t-test, Mann-Whitney, ANOVA, Kruskal-Wallis), Pearson/Spearman correlations, and multivariate regression models. ROC analysis will quantify discriminatory capacity. Economic evaluation will assess cost-effectiveness, cost-benefit, and resource utilization, considering reduced need for invasive monitoring and imaging.
Risk and Benefit
Risks are minimal, limited to local skin irritation from sensor placement. Potential benefits include earlier recognition of ICH, reduced reliance on invasive monitoring, improved triage decisions, and optimized healthcare resource allocation in the SUS.
- Being tested
- non-invasive intracranial pressure monitoring
- Keywords
- Stroke, Traumatic Brain Injury, Intracranial Pressure, Intracranial Compliance, Medical Devices
- Medical subject headings
- Brain Injuries, Traumatic, Hemorrhagic Stroke, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive intracranial pressure monitoringDevice
non-invasive intracranial pressure monitoring that provides continuous bedside monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic Brain Injury | Traumatic Brain Injury Receives: Device: non-invasive intracranial pressure monitoring | |
| Stroke | Stroke Receives: Device: non-invasive intracranial pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of non-invasive ICP and compliance parameters
Diagnostic accuracy of non-invasive ICP and compliance parameters (P2/P1 ratio, nTTP) obtained with the brain4care system for detecting intracranial hypertension, assessed by sensitivity, specificity, predictive values, and ROC curve analysis, using neuroimaging and clinical evaluation as reference standards.
Measured: From enrollment up to 14 days in the intensive care unit.
Secondary outcomes (1)
Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients
Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients, including CT-based scales (Marshall, Rotterdam, ASPECTS, Fisher, STICH, CRASH) and neurological scales (Glasgow Coma Scale, NIHSS, Hunt-Hess, WFNS, Rankin).
Measured: From enrollment up to 14 days in the intensive care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start16 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Braincare USA Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade Federal de Sergipe, Federal University of São Paulo, Federal University of Amazonas
- Responsible party
- Sponsor
- Investigators
- Robson L Oliveira de Amorim, PhD, Principal investigator, Federal University of AmazonasFabiano Moulin de Moraes, PhD, Principal investigator, Federal University of São PauloRita C Almeida Vieira, PhD, Principal investigator, Federal University of SergipeGustavo H Frigieri Vilela, PhD, Study chair, Braincare USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210333
- Sponsor's protocol ID
- b4cScreen
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and regulatory restrictions imposed by local ethics committees and data protection regulations.
Publications
R. d. A. P. Andrade et al., "A Nanometer Resolution Wearable Wireless Medical Device for Non Invasive Intracranial Pressure Monitoring," in IEEE Sensors Journal, vol. 21, no. 20, pp. 22270-22284, 15 Oct.15, 2021, doi: 10.1109/JSEN.2021.3090648
Frigieri G, Goncalves TL, Ocamoto GN, de Ap Andrade R, de Padua BC, Cardim D. Clinical Performance of the Brain4care System for Noninvasive Detection of Intracranial Hypertension. Neurocrit Care. 2025 Oct;43(2):628-635. doi: 10.1007/s12028-025-02273-6. Epub 2025 Apr 28.
PubMed 40293697Ocamoto GN, da Silva LN, da Silva Rocha Tomaz C, Hisatugu MT, Frigieri G, Cardim D, Goncalves RL, Russo TL, de Amorim RLO. Characterization of intracranial compliance in healthy subjects using a noninvasive method - results from a multicenter prospective observational study. J Clin Monit Comput. 2024 Dec;38(6):1249-1261. doi: 10.1007/s10877-024-01191-w. Epub 2024 Jul 20.
PubMed 39031230
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Enhancement of the Effectiveness of Non-invasive Intracranial Pressure Monitoring for Screening in Neurological Emergencies Within the Brazilian Unified Health System
- ClinicalTrials.gov ID
- NCT07210333
- Acronym / sponsor ID
- b4cScreen
- Keywords
- Stroke, Traumatic Brain Injury, Intracranial Pressure, Intracranial Compliance, Medical Devices
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Braincare USA CorpIndustry (pharma, biotech, devices)
- Collaborators
- Universidade Federal de Sergipe, Federal University of São Paulo, Federal University of Amazonas
- Study start
- 16 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 7 Oct 2025 (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.
The goal of this observational study is to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) pulse morphology and associated parameters (such as the P2/P1 ratio and nTTP) obtained with the brain4care system for the screening of intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke treated in Brazil's public health system (SUS).
The main questions it aims to answer are:
Can non-invasive ICP and ICC pulse morphology reliably identify or exclude intracranial hypertension, cerebral edema, and hemorrhage compared to CT findings and clinical/neurological evaluations?
Can this approach differentiate ischemic stroke from hemorrhagic stroke with sufficient accuracy?
Does the use of brain4care contribute to earlier detection, improved clinical decision-making, and cost reduction in emergency settings?
Detailed description
This is a prospective, observational, multicenter, longitudinal cohort study conducted in four Brazilian states (Amazonas, São Paulo, Sergipe, and Rio Grande do Sul). The study aims to evaluate the diagnostic accuracy of non-invasive intracranial pressure (ICP) and intracranial compliance (ICC) monitoring, using the brain4care system, for screening intracranial hypertension (ICH) in patients with traumatic brain injury (TBI) and stroke (ischemic or hemorrhagic) admitted to multiple levels of care in the Brazilian Unified Health System (SUS), including pre-hospital care (SAMU), primary care (UBS), urgent care units (UPA), emergency rooms (PS), and intensive care units (ICUs).
Study Procedures
Eligible participants (≥18 years) with TBI or stroke will undergo daily non-invasive ICP and ICC monitoring using the BWS 2.0 (Braincare Wireless System). Monitoring will be performed by trained medical and nursing teams, adjusted according to care setting:
SAMU (pre-hospital): 5 minutes of valid pulses during stabilization and transport.
UBS, UPA, and PS: 10 minutes of valid pulses during initial evaluation; repeated daily until transfer.
ICU: three times daily (every 8 hours) for 10 minutes during the first 72h, then twice daily (every 12 hours) for up to 14 days, each session lasting 30 minutes.
Clinical data include demographics, comorbidities, neurological exam findings (Glasgow Coma Scale, Cincinnati Stroke Scale, NIHSS, Hunt-Hess, WFNS, Rankin), and vital signs. Neuroimaging will be collected when available, with application of validated CT-based scales (Marshall, Rotterdam, ASPECTS, Fisher, STICH, CRASH).
Technology
The BWS 2.0 sensor applies piezoelectric technology to detect minute cranial deformations linked to ICP waveforms, allowing calculation of morphological parameters such as P2/P1 ratio and normalized Time-to-Peak (nTTP). Changes in these parameters reflect alterations in intracranial compliance, providing a non-invasive tool to identify or exclude ICH.
Data Collection and Quality Assurance
All data will be recorded in REDCap, a secure, validated data capture system. A data dictionary describes all study variables, coding conventions (e.g., MedDRA for clinical events), and reference ranges. Automated range and consistency checks will be applied during data entry. Source data verification will be performed by comparing REDCap records with hospital charts, imaging reports, and device outputs.
Site monitoring will ensure adherence to standard operating procedures (SOPs) for patient recruitment, informed consent, device handling, data collection, and reporting of adverse events. Periodic audits and central data review will reinforce data integrity.
Sample Size and Analysis
An initial sample of 300 patients was calculated to provide sufficient power for ROC curve analysis. The primary outcome is diagnostic performance (AUC, sensitivity, specificity, predictive values) of brain4care parameters against reference standards (CT and clinical scales). Secondary analyses include correlation with clinical and imaging findings, differentiation of ischemic vs. hemorrhagic stroke, and evaluation of cases with hemorrhagic transformation.
Statistical methods include parametric or non-parametric tests (t-test, Mann-Whitney, ANOVA, Kruskal-Wallis), Pearson/Spearman correlations, and multivariate regression models. ROC analysis will quantify discriminatory capacity. Economic evaluation will assess cost-effectiveness, cost-benefit, and resource utilization, considering reduced need for invasive monitoring and imaging.
Risk and Benefit
Risks are minimal, limited to local skin irritation from sensor placement. Potential benefits include earlier recognition of ICH, reduced reliance on invasive monitoring, improved triage decisions, and optimized healthcare resource allocation in the SUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury | – | Device: non-invasive intracranial pressure monitoringTraumatic Brain Injury |
| Stroke | – | Device: non-invasive intracranial pressure monitoringStroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) of both sexes presenting with clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic). Participants will be recruited from multiple levels of care within the Brazilian Unified Health System (SUS), including primary care units (UBS), urgent care units (UPA), pre-hospital emergency services (SAMU), hospital emergency rooms (PS), and intensive care units (ICUs) at participating hospitals in the states of Amazonas, São Paulo, Sergipe, and Rio Grande do Sul.
Key inclusion criteria (4 listed)
- Patients of both sexes.
- Age ≥ 18 years.
- Clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic).
- Signed informed consent form by the patient or by a legally authorized representative in cases where the patient is unable to consent due to the severity of the clinical condition. If the legal representative is not present at the time of admission or initial care, consent may be obtained retrospectively.
Key exclusion criteria (6 listed)
- Individuals with brain lesions of other etiologies, such as previous TBI and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, or illicit drug use.
- Individuals with scalp or skin lacerations that prevent proper placement of the brain4care sensor.
- Individuals with craniectomy or skull fractures.
- Individuals with severe debilitating mental health disorders and/or severe debilitating neurological diseases.
- Individuals who are agitated, aggressive, or uncooperative, preventing 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 |
|---|---|---|
| non-invasive intracranial pressure monitoringnon-invasive intracranial pressure monitoring that provides continuous bedside monitoring. | Device | Stroke, Traumatic Brain Injury |
Primary outcome
Diagnostic accuracy of non-invasive ICP and compliance parameters
Time frame: From enrollment up to 14 days in the intensive care unit.
Diagnostic accuracy of non-invasive ICP and compliance parameters (P2/P1 ratio, nTTP) obtained with the brain4care system for detecting intracranial hypertension, assessed by sensitivity, specificity, predictive values, and ROC curve analysis, using neuroimaging and clinical evaluation as reference standards.
1 secondary outcome
Correlation of non-invasive ICP/ICC parameters with clinical and imaging findings in TBI and stroke patients
Time frame: From enrollment up to 14 days in the intensive care unit.
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 7 Oct 2025.
- BackgroundR. d. A. P. Andrade et al., "A Nanometer Resolution Wearable Wireless Medical Device for Non Invasive Intracranial Pressure Monitoring," in IEEE Sensors Journal, vol. 21, no. 20, pp. 22270-22284, 15 Oct.15, 2021, doi: 10.1109/JSEN.2021.3090648
- Background: PubMed 40293697Frigieri G, Goncalves TL, Ocamoto GN, de Ap Andrade R, de Padua BC, Cardim D. Clinical Performance of the Brain4care System for Noninvasive Detection of Intracranial Hypertension. Neurocrit Care. 2025 Oct;43(2):628-635. doi: 10.1007/s12028-025-02273-6. Epub 2025 Apr 28.
- Background: PubMed 39031230Ocamoto GN, da Silva LN, da Silva Rocha Tomaz C, Hisatugu MT, Frigieri G, Cardim D, Goncalves RL, Russo TL, de Amorim RLO. Characterization of intracranial compliance in healthy subjects using a noninvasive method - results from a multicenter prospective observational study. J Clin Monit Comput. 2024 Dec;38(6):1249-1261. doi: 10.1007/s10877-024-01191-w. Epub 2024 Jul 20.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and regulatory restrictions imposed by local ethics committees and data protection regulations.
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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.
Robson L Oliveira de Amorim, PhD principal investigator
Federal University of Amazonas
Fabiano Moulin de Moraes, PhD principal investigator
Federal University of São Paulo
Rita C Almeida Vieira, PhD principal investigator
Federal University of Sergipe
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury (TBI) Patients and Stroke Hemorrhagic, run by Braincare USA Corp at 3 sites in Brazil.
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 4 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 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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 Danilo A Cardim, PhD ((424) 888-2942, danilo.cardim@brain4.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of non-invasive ICP and compliance parameters (time frame: From enrollment up to 14 days in the intensive care unit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07210333, which also lists 3 linked publications.
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 7 Oct 2025.