NCT05433948

Diagnosing Minimal Hepatic Encephalopathy

Diagnostik Af Minimal Hepatisk Encephalopati: Association Mellem Kontinuert Reaktionsstidsmåling Og EEG-indices

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 550 (estimated)
• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Conditions

• Hepatic Encephalopathy
• Liver Cirrhosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Simultaneous EEG and CRT	EEG is recorded with 32 electrodes and commercial recording equipment.10 min EEG is recorded in idle mode with eyes closed prior to continuous EEG recording during the CRT examination, see below. The test is performed via a laptop using EKHO software. The software generates 150 sound stimuli of 90 dB, which the patient hears in sound-insulated headphones. Via a push button in the dominant hand, the patient must respond as quickly as possible as soon as sounds are perceived. PSE test: Duration 20 min. Includes 5 tasks: Digit-symbol Test, Number Connecting Test A, Number Connecting Test B, Serial Dotting Test and Line Tracing Test. Exits in 4 versions, which are used in repeated tests to avoid the learning effect. Scores range from -18 t0 6 and less -4 is abnormal.

Timeline

• Start date: 2019-12-01
• Primary completion: 2026-12-01
• Completion: 2031-12-01
• First posted: 2022-06-27
• Last updated: 2024-12-02

Locations

1 site across 1 country: Denmark