Hospital of South West Jutland
Esbjerg, 6700, Denmark
NCT Number: NCT05433948
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
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Esbjerg, 6700, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients with liver cirrhosis:
For the subgroup with liver cirrhosis and normal cognition:
For the subgroup with liver cirrhosis and minimal hepatic encephalopathy:
For the subgroup with liver cirrhosis and HE grade 2, the following applies:
Inclusion criteria
healthy:
Inclusion criteria
for pre-cirrhosis liver disease:
As for healthy controls plus:
Exclusion criteria
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.
Other names: PSE test, Animal Naming Test
Time frame: Up to 60 months
During CRT 150 reaction times are measured. Investigators want to measure if prolonged reaction times >75 percentile are preceded by spectral and frequency changes in EEG. For EEG investigators will assess relative theta and delta activity. EEG and CRT will be done simultaneously.
Time frame: Up to 60 months
Apply mathematically modeled time analysis to establish cyclicity in the 150 measures reaction times and examine if cyclic activity correlates to relative theta and delta activity in the EEG.
Time frame: Up to 60 months
Some patients will be found eligible for treatment with lactulose or rifaximin due to signs of minimal hepatic encephalopathy. Investigators will use EEG relative theta and delta activity to measure the efficacy of the treatment.
Esbjerg Hospital - University Hospital of Southern Denmark
Other
Diagnostik Af Minimal Hepatisk Encephalopati: Association Mellem Kontinuert Reaktionsstidsmåling Og EEG-indices
Acronym: MindTheLiver
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