Development of a Cognitive Tool for Rapid and Reliable Screening of Minimal Hepatic Encephalopathy: Pilot Study
BLOCK-HE
1 other identifier
observational
100
1 country
1
Brief Summary
The aim of this project is to evaluate the sensitivity and specificity of a cognitive test toward the presence of minimal hepatic encephalopathy (MHE). MHE is a neurological complication due to hepatic dysfunction and/or the presence of porto-systemic shunts defined by the presence of neurocognitive impairments (NI). Other factors of brain injury may cause NI independently from the liver condition making the differential diagnosis difficult using available cognitive tests (ANT Animal Naming Test, PHES Psychometric Hepatic Encephalopathy Score, CFF Critical Flicker Frequency test). The cognitive test evaluated in this project is a construction task using construction blocks, allowing the evaluation of psychomotor speed, executive functions, attention, and episodic memory. The measures will be compared to other cognitive tests validated for the evaluation of the targeted cognitive functions (PHES, Mesulam Cancelling task, Rey-Osterrieth complex figure, Free and Cued Selective Reminding Test) and cognitive tests validated for the diagnosis of MHE (PHES, ANT, CFF). The diagnosis of MHE is based on an adjudication committee including a multimodal assessment of MHE (brain MRI with spectroscopy, EEG, blood sample, neuropsychological assessment), allowing the evaluation of comorbidities such as other factors of brain injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
January 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 29, 2028
February 18, 2026
February 1, 2026
2 years
September 26, 2024
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensitivity and specificity of the construction test according to the diagnosis of MHE, after construction of a logistic model.
between day 0 and 14 from inclusion
Secondary Outcomes (3)
Comparison of the sensitivities and specificities of the construction test compared to the MHE reference tests
Between day 0 and 14 from inclusion
Evaluate the sensitivity and specificity of the construction test for the diagnosis of hepatic encephalopathy, taking into account the presence of neurological comorbidities.
Between day 0 and 14 from inclusion
Correlation analysis between subsets of the construction test (planning, speed, selective attention, memory) with reference cognitive tests assessing these cognitive functions
Between day 0 and 14 from inclusion
Study Arms (1)
Patients
Population with chronic liver disease or the presence of portal-systemic shunts, attending the BLIPS day hospital
Interventions
Eligibility Criteria
Patients with liver cirrhosis or portosystemic shunts with suspicion of minimal hepatic encephalopathy
You may qualify if:
- Age between 18 and 70 years
- Hepatic pathology (fibrosis, cirrhosis, porto-systemic shunts)
- Evaluation at BLIPS clinic (neuropsychological assessment, MRI, EEG and blood sample with ammonia)
You may not qualify if:
- Opposition to participating in the study
- Not being affiliated with French healthcare system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hepato-gastro-enterology department, Pitié Salpêtrière hospital
Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicolas WEISS, MD,PhD
Assistance Publique - Hôpitaux de Paris
- STUDY DIRECTOR
Dominique THABUT, MD, PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2024
First Posted
October 1, 2024
Study Start
January 29, 2026
Primary Completion (Estimated)
January 29, 2028
Study Completion (Estimated)
January 29, 2028
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal.
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.