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| Name | Class |
|---|---|
| Regionshospitalet Silkeborg | OTHER |
| Herlev Hospital | OTHER |
| Aalborg University Hospital | OTHER |
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Our purpose is to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver cirrhosis with normal cognition | Liver cirrhosis and performs normally in all psychometric tests. n=100 |
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| Liver cirrhosis with minimal hepatic encephalopathy | Liver cirrhosis and performs abnormally en 2 or more psychometric test. n=100 |
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| Liver cirrhosis and overt hepatic encephalopathy | West Haven grade 2 or more. n=50 |
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| Healthy control persons | Completely healthy persons, age, and gender-matched to cirrhosis patients. n=100 |
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| Sick control persons | Persons with other chronic diseases than liver disease. n=100 |
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| Pre-cirrhotic liver disease | Not yet cirrhosis. Will primarily be NAFLD patients. n=100 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous EEG and CRT | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concordant changes in reaction times and in EEG spectral and frequency analysis | 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. | Up to 60 months |
| Observation of cyclic activity in continous reaction times (CRT measures) | 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. | Up to 60 months |
| Change in EEG spectral and frequency analysis with a clinically indicated standard treatment for minimal hepatic encephalopathy | 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. | Up to 60 months |
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Inclusion criteria for patients with liver cirrhosis:
For the subgroup with liver cirrhosis and normal cognition:
Normal result in PSE and CRT testing and clinical examination without evidence of HE
For the subgroup with liver cirrhosis and minimal hepatic encephalopathy:
Abnormal result in PSE and / or CRT test, but oriented in time, place and own data.
For the subgroup with liver cirrhosis and HE grade 2, the following applies:
Abnormal PSE and CRT result and / or disoriented in time, place or own data and / or asterixis or other clinical symptoms of HE
Ability to collaborate on the performance of CRT test, PSE test and EEG
Inclusion criteria healthy:
Inclusion criteria for pre-cirrhosis liver disease:
As for healthy controls plus:
Exclusion Criteria:
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See *cohorts'.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of South West Jutland | Esbjerg | 6700 | Denmark |
Only anonymized data will be shared if needed due to local regulations.
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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A biobank will be set up containing blood, urine, saliva, and feces from the project participants, incl. the healthy control persons.
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| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |