Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
550 participants
OBSERVATIONAL
2019-12-01
2031-12-01
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Liver cirrhosis with normal cognition
Liver cirrhosis and performs normally in all psychometric tests. n=100
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.
Liver cirrhosis with minimal hepatic encephalopathy
Liver cirrhosis and performs abnormally en 2 or more psychometric test. n=100
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.
Liver cirrhosis and overt hepatic encephalopathy
West Haven grade 2 or more. n=50
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.
Healthy control persons
Completely healthy persons, age, and gender-matched to cirrhosis patients. n=100
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.
Sick control persons
Persons with other chronic diseases than liver disease. n=100
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.
Pre-cirrhotic liver disease
Not yet cirrhosis. Will primarily be NAFLD patients. n=100
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Liver cirrhosis verified by biopsy or appropriate clinic and biochemistry as well as imaging.
3. Written informed consent
4. Speaks and understands Danish
For the subgroup with liver cirrhosis and normal cognition:
1. Normal result in PSE and CRT testing and clinical examination without evidence of HE
For the subgroup with liver cirrhosis and minimal hepatic encephalopathy:
2. 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:
3. Abnormal PSE and CRT result and / or disoriented in time, place or own data and / or asterixis or other clinical symptoms of HE
4. Ability to collaborate on the performance of CRT test, PSE test and EEG
1. Liver healthy
2. Age over 18 years
3. Formal education ≤ 14 years
4. Written informed consent
5. Speaks and understands Danish
As for healthy controls plus:
1. In our local outpatient clinic
2. Proven pre-cirrhosis liver disease
Exclusion Criteria
2. Hyponatraemia (Na \<124 mmol / L)
3. Sepsis one week prior to tests.
4. Heart failure (EC less than 30% or NYHA class III and IV)
5. Severe chronic obstructive pulmonary disease (GOLD stage 3 and 4 ie FEV1 / FVC below 0.7 and FEV1 \<50% of expected value)
6. Highly controllable diabetes (HbA1C\> 60 mmol / mol)
7. Renal failure (eGFR below 60)
8. Known neurological diseases (epilepsy, stroke, dementia)
9. Intake of coffee or alcohol 6 hours before tests and change of dose in psychoactive drugs within 6 days of the test (morphine, antipsychotics, antidepressants) -
18 Years
90 Years
ALL
Yes
Sponsors
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Regionshospitalet Silkeborg
OTHER
Herlev Hospital
OTHER
Aalborg University Hospital
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Responsible Party
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Mette Munk Lauridsen
Associate professor
Locations
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Hospital of South West Jutland
Esbjerg, , Denmark
Countries
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Other Identifiers
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S-20180127
Identifier Type: -
Identifier Source: org_study_id