Condition: Hepatic Pathology (Fibrosis, Cirrhosis, Porto Systemic Shunts) · Sponsor: Assistance Publique - Hôpitaux de Paris
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.
This description comes directly from the study's public registry record.
Lyès KHELOUFI · 01 84 82 74 83 · lyes.kheloufi@aphp.fr
Nicolas WEISS, MD,PhD · 01 42 16 27 70 · nicolas.weiss@aphp.fr
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| Hepato-gastro-enterology department, Pitié Salpêtrière hospital | Paris, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06619106