Hepatic EncephalopathyMindTheLiverNCT05433948
Diagnosing Minimal Hepatic Encephalopathy
An observational study of Hepatic Encephalopathy and Liver Cirrhosis, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Encephalopathy, Liver Cirrhosis
- What is being tested?
- Simultaneous EEG and CRT
- How many people
- 550 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2019to 1 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: See *cohorts'.
Who may be able to join
- Age> 18
- Liver cirrhosis verified by biopsy or appropriate clinic and biochemistry as well as imaging.
- Written informed consent
- Speaks and understands Danish
- For the subgroup with liver cirrhosis and normal cognition:
- Normal result in PSE and CRT testing and clinical examination without evidence of HE
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- 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
- Liver healthy
- Age over 18 years
- Formal education ≤ 14 years
- Written informed consent
- Speaks and understands Danish
- As for healthy controls plus:
- In our local outpatient clinic
- Proven pre-cirrhosis liver disease
Who cannot join
- Organic brain disease (eg previous epilepsy, apoplexy, dementia)
- Hyponatraemia (Na <124 mmol / L)
- Sepsis one week prior to tests.
- Heart failure (EC less than 30% or NYHA class III and IV)
- Severe chronic obstructive pulmonary disease (GOLD stage 3 and 4 ie FEV1 / FVC below 0.7 and FEV1 <50% of expected value)
- Highly controllable diabetes (HbA1C> 60 mmol / mol)
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- Renal failure (eGFR below 60)
- Known neurological diseases (epilepsy, stroke, dementia)
- 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) -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostik Af Minimal Hepatisk Encephalopati: Association Mellem Kontinuert Reaktionsstidsmåling Og EEG-indices
Our purpose is to
- 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
- 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.
- 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.
- 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.
- 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
- To establish Danish normal values for the PSE test and the Animal Naming test in Danes
- Conditions
- Hepatic Encephalopathy, Liver Cirrhosis
- Being tested
- Simultaneous EEG and CRT
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous EEG and CRTDiagnostic test
Also called PSE test, Animal Naming 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.
| Study group | Role | What they receive |
|---|---|---|
| Liver cirrhosis with normal cognition | Liver cirrhosis and performs normally in all psychometric tests. n=100 Receives: Diagnostic Test: Simultaneous EEG and CRT | |
| Liver cirrhosis with minimal hepatic encephalopathy | Liver cirrhosis and performs abnormally en 2 or more psychometric test. n=100 Receives: Diagnostic Test: Simultaneous EEG and CRT | |
| Liver cirrhosis and overt hepatic encephalopathy | West Haven grade 2 or more. n=50 Receives: Diagnostic Test: Simultaneous EEG and CRT | |
| Healthy control persons | Completely healthy persons, age, and gender-matched to cirrhosis patients. n=100 Receives: Diagnostic Test: Simultaneous EEG and CRT | |
| Sick control persons | Persons with other chronic diseases than liver disease. n=100 Receives: Diagnostic Test: Simultaneous EEG and CRT | |
| Pre-cirrhotic liver disease | Not yet cirrhosis. Will primarily be NAFLD patients. n=100 Receives: Diagnostic Test: Simultaneous EEG and CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Dec 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Silkeborg, Herlev Hospital, Aalborg University Hospital
- Responsible party
- Principal investigator, Mette Munk Lauridsen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433948
- Sponsor's protocol ID
- S-20180127
- Acronym
- MindTheLiver
- Status last verified
- Nov 2024
- First submitted
- 12 Jun 2022
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymized data will be shared if needed due to local regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostik Af Minimal Hepatisk Encephalopati: Association Mellem Kontinuert Reaktionsstidsmåling Og EEG-indices
- ClinicalTrials.gov ID
- NCT05433948
- Acronym / sponsor ID
- MindTheLiver / S-20180127
- Conditions
- Hepatic Encephalopathy, Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Regionshospitalet Silkeborg, Herlev Hospital, Aalborg University Hospital
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our purpose is to
- 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
- 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.
- 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.
- 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.
- 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
- To establish Danish normal values for the PSE test and the Animal Naming test in Danes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Liver cirrhosis with normal cognition | – | Diagnostic Test: Simultaneous EEG and CRTLiver cirrhosis and performs normally in all psychometric tests. n=100 |
| Liver cirrhosis with minimal hepatic encephalopathy | – | Diagnostic Test: Simultaneous EEG and CRTLiver cirrhosis and performs abnormally en 2 or more psychometric test. n=100 |
| Liver cirrhosis and overt hepatic encephalopathy | – | Diagnostic Test: Simultaneous EEG and CRTWest Haven grade 2 or more. n=50 |
| Healthy control persons | – | Diagnostic Test: Simultaneous EEG and CRTCompletely healthy persons, age, and gender-matched to cirrhosis patients. n=100 |
| Sick control persons | – | Diagnostic Test: Simultaneous EEG and CRTPersons with other chronic diseases than liver disease. n=100 |
| Pre-cirrhotic liver disease | – | Diagnostic Test: Simultaneous EEG and CRTNot yet cirrhosis. Will primarily be NAFLD patients. n=100 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- See *cohorts'.
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (9 listed)
- Organic brain disease (eg previous epilepsy, apoplexy, dementia)
- Hyponatraemia (Na <124 mmol / L)
- Sepsis one week prior to tests.
- Heart failure (EC less than 30% or NYHA class III and IV)
- Severe chronic obstructive pulmonary disease (GOLD stage 3 and 4 ie FEV1 / FVC below 0.7 and FEV1 <50% of expected value)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous EEG and CRTAlso: PSE test, Animal Naming TestEEG 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. | Diagnostic test | Healthy control persons, Liver cirrhosis and overt hepatic encephalopathy, Liver cirrhosis with minimal hepatic encephalopathy, Liver cirrhosis with normal cognition, Pre-cirrhotic liver disease, Sick control persons |
Primary outcome
Concordant changes in reaction times and in EEG spectral and frequency analysis
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.
Observation of cyclic activity in continous reaction times (CRT measures)
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.
Change in EEG spectral and frequency analysis with a clinically indicated standard treatment for minimal hepatic encephalopathy
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No. Only anonymized data will be shared if needed due to local regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Encephalopathy and Liver Cirrhosis, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordant changes in reaction times and in EEG spectral and frequency analysis (time frame: Up to 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.