Trial document





This trial has been registered retrospectively.
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  DRKS00009432

Trial Description

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Title

Evaluation of a novel tablet-PC-based number connection test (eNCT)

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Trial Acronym

eNCT

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URL of the Trial

http://wftl.eu/enct-studie.html

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Brief Summary in Lay Language

Two of three patients with liver cirrhosis suffer at least once from hepatic encephalopathy (HE), an often reversible impairment of brainfunction. Early and reliable HE-diagnosis may help to reduce more severe complications and to improve quality of life and longtime survival. Up to date, there is no reliable self-test that can be done by the patient himself, at home and without additional help.
Aim of this study is to evaluate a newly developed electronic number connection test as a patients' self-test for the home environment.

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Brief Summary in Scientific Language

Methodological study to evaluate a newly developed number connection test in comparison to well-established paper-based tests (e.g. Psychometric Hepatic Encephalopathy Score) for detection of minimal hepatic encephalopathy.

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Organizational Data

  •   DRKS00009432
  •   2015/10/15
  •   [---]*
  •   yes
  •   Approved
  •   EA1/263/14, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K72.7 -  [generalization K72: Hepatic failure, not elsewhere classified]
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Interventions/Observational Groups

  •   Reference Group: Applying Psychometric Hepatic Encephalopathy Score (PHES), Electronic Number Connection Test (eNCT) and StroopApp Test once or twice (after time interval).
  •   Cirrhotic Patients with Hepatic Encephalopathy: Applying Psychometric Hepatic Encephalopathy Score (PHES), Electronic Number Connection Test (eNCT) and StroopApp Test once or twice (after time interval).
  •   Young, Healthy Control Subjects: Applying Psychometric Hepatic Encephalopathy Score (PHES), Electronic Number Connection Test (eNCT) and StroopApp Test once or twice (after time interval).
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

test validity: correlation of the newly developed eNCT results with test times of well-established paper-pencil tests of the Psychometric Hepatic Encephalopathy Score test battery

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Secondary Outcome

test-retest-reliability; participants repeat the test procedure twice, with at least 4 days between the test and retest

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/10
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. healty subjects (at least 18 years old)
2. patients (at least 18 years old) with histologically confirmed liver cirrhosis of every reasons (including alcoholic liver disease) or who are suspected to have liver cirrhosis because of existence of complications like ascites, varices, hepatic encephalopathy or increased part of connective tissue in the liver.
3. no florid abuse of alcohol or drugs in the last 6 months before study inclusion.
4. patients who gave there informed consent in written form

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Exclusion Criteria

1. mini-mental status score <25
2. known impairment of red and green vision
3. known neurological/psychiatric disease which affects the cognitive performance (besides hepatic encephalopathy)
4. knwon neurological/psychiatric disease with intake of medicine that affects the central nervous system (e.g. benzodiazepines or some sleeping pills)

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Addresses

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    • Charité - Universitätsmedizin BerlinKlinik für Allgemein-, Visceral- und Transplantationschirurgie
    • Mr.  PD Dr. med.  Martin   Stockmann 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    •   [---]*
    •   [---]*
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    • Klinik für Allgemein-, Visceral- und TransplantationschirurgieCharité Campus Virchow-Klinikum
    • Mr.  Dr.  Martin  Stockmann 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Klinik für Allgemein-, Visceral- und TransplantationschirurgieCharité Campus Virchow-Klinikum
    • Mr.  Dr.  Tilo  Wuensch 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • European Commission
    • 1049  Brüssel
    • Belgium
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/08/31
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Trial Publications, Results and other Documents

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