Rapid block-building cognitive test to screen for minimal hepatic encephalopathy
Development of a Cognitive Tool for Rapid and Reliable Screening of Minimal Hepatic Encephalopathy: Pilot Study
We will test a short block-building cognitive task to see if it can detect minimal hepatic encephalopathy in adults with liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06619106 on ClinicalTrials.gov |
What this trial studies
This observational pilot compares a brief construction-block task to established neuropsychological tests and biological/functional measures to detect minimal hepatic encephalopathy (MHE). The block task targets psychomotor speed, attention, executive function, and episodic memory and is meant to be rapid and easy to administer. Participants undergo the block test alongside validated tests such as the PHES, Mesulam cancelling task, Rey-Osterrieth Complex Figure, and Free and Cued Selective Reminding Test, plus EEG, MRI and ammonia measurement when available. Sensitivity and specificity of the block task for identifying MHE will be calculated against these reference measures to determine its diagnostic utility.
Who should consider this trial
Good fit: Adults aged 18–70 with hepatic pathology (fibrosis, cirrhosis, or portosystemic shunts) who are being evaluated at the BLIPS clinic and are covered by the French healthcare system are eligible.
Not a fit: People outside the age range, without liver disease, not affiliated with the French healthcare system, or whose cognitive impairment is caused by other non-hepatic brain diseases may not benefit from this screening approach.
Why it matters
Potential benefit: If successful, the test could provide a quick, low-cost way to screen people with liver disease for subtle cognitive problems and help identify those needing further care.
How similar studies have performed: Existing tools such as PHES and critical flicker frequency have some diagnostic value for MHE, but applying a block-construction task for this purpose is a novel approach that has not been widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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) Exclusion Criteria: * Opposition to participating in the study * Not being affiliated with French healthcare system
Where this trial is running
Paris
- Hepato-gastro-enterology department, Pitié Salpêtrière hospital — Paris, France (Recruiting)
Study contacts
- Study coordinator: Lyès KHELOUFI
- Email: lyes.kheloufi@aphp.fr
- Phone: 01 84 82 74 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.