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
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age\> 18
. Liver cirrhosis verified by biopsy or appropriate clinic and biochemistry as well as imaging.
. Written informed consent
. Speaks and understands Danish
. Normal result in PSE and CRT testing and clinical examination without evidence of HE
. Abnormal result in PSE and / or CRT test, but oriented in time, place and own data.
. Abnormal PSE and CRT result and / or disoriented in time, place or own data and / or asterixis or other clinical symptoms of HE
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concordant changes in reaction times and in EEG spectral and frequency analysis
Timeframe: Up to 60 months
2
Observation of cyclic activity in continous reaction times (CRT measures)
Timeframe: Up to 60 months
3
Change in EEG spectral and frequency analysis with a clinically indicated standard treatment for minimal hepatic encephalopathy
Timeframe: Up to 60 months
Trial details
NCT IDNCT05433948
SponsorEsbjerg Hospital - University Hospital of Southern Denmark