Clinical Trial

Diagnosing Minimal Hepatic Encephalopathy

Study acronym: MindTheLiver
Enrolling by Invitation
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Summary
Our purpose is to 1. Examine the correlation between MDF in a resting EEG, recorded just before the CRT test, and the variance in reaction times indicated by the CRT index 2. At simultaneous CRT and EEG recording, examine whether a change in EEG is seen immediately before an extended reaction time occurs (defined by the 75th percentile). This will shed light on a direct pathophysiological association between what is measured with EEG and CRT. 3. Investigate whether cyclicity can be detected in the continuous reaction times and if so, whether amplitude and wavelength in this cyclic activity are correlated to EEG parameters. 4. Examine whether a response to standard HE treatment can be detected with EEG in patients who are thought to suffer from it. As well as if baseline outcome predict future hepatic encephalopathy. 5. With a view to further validating our findings, investigators want to correlate results from EEG and CRT with the most internationally widespread psychometric test, the Portosystemic Encephalopathy test (PSE), which necessitates the establishment of Danish normal values. A secondary purpose of this study is therefore 6. To establish Danish normal values for the PSE test and the Animal Naming test in Danes
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-06-22; most recent amendment 2024-11-27.
Trial Details
NCT Number NCT05433948
Lead Sponsor Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: Regionshospitalet Silkeborg, Herlev Hospital, Aalborg University Hospital
Conditions Hepatic Encephalopathy, Liver Cirrhosis
Enrollment 550 participants
Start Date 2019-12-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2031-12-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-02