Trial document




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  DRKS00011354

Trial Description

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Title

Comparison of compiled items for people with intellectual disability and the items of EpiTrack Junior, to be applied to people with intellectual disability

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In the study at hand, people with intellectual disabiliy are tested neuropsychologically. In particular, the potential cognitive side effects of antiepileptic drugs are examined. It is evaluated whether the compiled cognitive items are more suitable than the items of an established test procedure (EpiTrack Junior).
For this purpose, EpiTrack Junior, and in a further session the compiled items (Non-EpiTrack test battery), are presented to 30 patients with mild to moderate intellecutal disability.

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Brief Summary in Scientific Language

In the study at hand, people with intellectual disabiliy are tested neuropsychologically. In particular, the potential cognitive side effects of antiepileptic drugs are examined. It is evaluated whether the compiled cognitive items are more suitable than the items of an established test procedure (EpiTrack Junior).
For this purpose, EpiTrack Junior, and in a further session the compiled items (Non-EpiTrack test battery), are presented to 30 patients with mild to moderate intellecutal disability.

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Organizational Data

  •   DRKS00011354
  •   2017/02/21
  •   [---]*
  •   yes
  •   Approved
  •   155/2016, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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

  •   epilepsy, intellectual disability
  •   G40 -  Epilepsy
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Interventions/Observational Groups

  •   'EpiTrack Junior', a test for acquisition of cognitive changes that can be caused by antiepileptic medication.
  •   Non-EpiTrack test battery, compiled cognitive items for acquisition of cognitive changes that can be caused by antiepileptic medication.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Usability of different neuropsychological test items.
It will be tested whether the exercises can be understood by people with ID, whether they can solve the exercises, what difficulties arise, how long they take and whether floor or ceiling effects arise.

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Secondary Outcome

Duration of testing procedure and affective contribution of the test persons.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/02/22
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   35   Years
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Additional Inclusion Criteria

Mild to moderate intellectual disability, previously diagnosed epilepsy

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Exclusion Criteria

Severe visual impairment, German is not first language, language comprehension severely impaired, physically unable to hold a pen, dementia, no consent of legal guardian or test person

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Addresses

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    • Agaplesion Diakonieklinikum Rotenburg (Wümme)
    • Ms.  Schäfer 
    • Elise-Averdieck-Straße 17
    • 27356  Rotenburg
    • Germany
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    • Agaplesion Diakonieklinikum Rotenburg (Wümme)
    • Ms.  Ulrike  Schäfer 
    • Elise-Averdieck-Straße 17
    • 27356  Rotenburg (Wümme)
    • Germany
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    • Agaplesion Diakonieklinikum Rotenburg (Wümme)
    • Ms.  Ulrike  Schäfer 
    • Elise-Averdieck-Straße 17
    • 27356  Rotenburg (Wümme)
    • Germany
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Sources of Monetary or Material Support

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    • Agaplesion Diakonieklinikum Rotenburg (Wümme)
    • Ms.  Schäfer 
    • Elise-Averdieck-Straße 17
    • 27356  Rotenburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/09/07
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Trial Publications, Results and other Documents

  •   Nicht angestrebt.
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* This entry means the parameter is not applicable or has not been set.