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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Hepato-gastro-enterology department, Pitié Salpêtrière hospital
RECRUITING
Paris
Contact Information
Primary
Lyès KHELOUFI
lyes.kheloufi@aphp.fr
01 84 82 74 83
Backup
Nicolas WEISS, MD,PhD
nicolas.weiss@aphp.fr
01 42 16 27 70
Time Frame
Start Date: 2026-01-29
Estimated Completion Date: 2028-01-29
Participants
Target number of participants: 100
Treatments
Patients
Population with chronic liver disease or the presence of portal-systemic shunts, attending the BLIPS day hospital
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov