Development of a Cognitive Tool for Rapid and Reliable Screening of Minimal Hepatic Encephalopathy: Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-18

Study Completion Date

2027-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension

NCT04807803

Cirrhosis Portal Hypertension

RECRUITING NA

Metobolomics in the Characterisation of HE

NCT06245473

Hepatic Encephalopathy Cirrhosis

COMPLETED

Early Diagnosis and Timely Treatment of Cirrhotic Patients With Minimal Hepatic Encephalopathy (CHESS-NCRCID 2106)

NCT05140837

Hepatic Encephalopathy Cirrhosis

UNKNOWN

A Study of MHE in Patients With Liver Diseases

NCT04058327

Hepatic Encephalopathy Minimal Hepatic Encephalopathy Overt Hepatic Encephalopathy

COMPLETED

Psychometric Hepatic Encephalopathy Score in Prediction of Minimal Hepatic Encephalopathy in Compensated Cirrhotic Patients

NCT07272707

Minimal Hepatic Encephalopathy

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hepatic encephalopathy (HE), corresponding to all the neurocognitive symptoms caused by liver damage and/or the presence of portosystemic shunts. HE can take several forms depending on its intensity, ranging from subtle neuropsychological abnormalities that are difficult to detect during a routine interview ("minimal" HE, MHE) to temporospatial disorientation and confusion that can lead to coma ( "overt" HE, OHE). MHE can significantly impair the quality of life of patients and caregivers; it is associated with a poorer prognosis of liver pathology and a significantly more frequent occurrence of OHE. Detection of MHE is complex, and involves the convergence of a large number of tests recognized as sensitive: venous ammonia level, electroencephalogram, MRI with spectroscopy, complete neuropsychological assessment. Today, there is no unanimously recognized Gold Standard.

The objective of this research project is to develop a cognitive test to detect HE sensitively and specifically, in order to detect HE.

To do this, the investigators will evaluate the qualities of a rapid and accessible test. It is a test made up of building blocks to assess psychomotor speed, attention, executive functions and episodic memory. If it proves sensitive and specific enough for the diagnosis of MHE, it could be disseminated and allow the screening of MHE.

To do this, the investigators will compare the block construction test to other neuropsychological examinations validated in the diagnosis of MHE (PHES: Psychometric Hepatic Encephalopathy Score, CFF: Critical Flicker Frequency test, ANT: Animal Naming Test). These examinations are reference cognitive tests in the diagnosis of MHE, but the results between these tests diverge and do not currently make it possible to replace all of the clinical examinations described above. The investigators will also compare the construction block test to cognitive tests validated for the evaluation of the targeted cognitive functions (ROCF Rey-Osterrieth complex figure, FCSRT Free and Cued Selective Reminding test, MCT Mesulam cancelling task). 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.

Main objective : to evaluate the sensitivity and specificity of the construction test to the presence of MHE.

Secondary objectives:

1. Comparison of screening qualities of the construction test to MHE diagnosis validated tests (PHES, CFF, ANT)
2. Evaluate the impact of the presence of comorbidities (factors of brain injury) in the results of the construction test.
3. Evaluate the psychometric qualities of the construction test compared to validated neuropsychological tests.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Pathology (Fibrosis, Cirrhosis, Porto Systemic Shunts)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

Population with chronic liver disease or the presence of portal-systemic shunts, attending the BLIPS day hospital

Cognitive test

Intervention Type OTHER

Cognitive test based on building blocks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive test

Cognitive test based on building blocks

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)