Trial document




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  DRKS00014951

Trial Description

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Title

Comparative study of the perception of visually and acustically mediated prominence in healthy control subjects and people with autism spectrum disorder

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We have different means of directing somebody else's attention towards an object in the environment. For example, we can achieve this by using eye gaze and speech. People with autism spectrum disorder may perceive these means to shift attention differently from people without autism spectrum disorder.

The aim of this study is to better understand the impact of both means for shifting attention (eye gaze and speech) on the rating of participants regarding the importance that certain objects have for a virtual character as well as on a measure of attention. In the fMRI study part, brain activation patterns during the rating task will be measured and compared between the groups.

Potential study participants are people with and without autism spectrum disorder (Asperger syndrome).

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Brief Summary in Scientific Language

We have different means of directing somebody else's attention towards an object in the environment. For example, we can achieve this with eye gaze behaviour as well as with prosody. People with autism spectrum disorder may perceive these means to shift attention differently from people without autism spectrum disorder.

The aim of this study is to better understand the impact of both means for shifting attention (eye gaze and prosody) on the rating of participants regarding the importance that certain objects have for a virtual character as well as on a measure of attention. In the fMRI study part, brain activation patterns during thes rating task will be measured and compared between the groups.

Potential study participants are people with and without autism spectrum disorder (F84.5: Asperger syndrome).

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Organizational Data

  •   DRKS00014951
  •   2019/05/10
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  •   yes
  •   Approved
  •   18-211, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   F84.5 -  Asperger syndrome
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Interventions/Observational Groups

  •   People without a diagnosis from the autism spectrum are included.

    Screening tools for comparison with data collected in the study will be completed: AQ, EQ, SQ

    A general questionnaire for the collection of demographic data will be completed, as well as a screening instrument for the short recording of depressive symptoms (BDI-2).

    A verbal IQ test (WST) and a test to assess attentional load (D2) will be completed.

    A questionnaire on MRI safety is completed (applies only to the fMRI part of the study).

    Participants work on a paradigm. The participants watch short video sequences and give an assessment of the videos by button presses (in the fMRI study part, this part of the study takes place in the fMRI scanner).

    A follow-up questionnaire on the MRI experience is completed (applies only to the fMRI study part).

    Participants work on a reaction time task on the computer screen. Here, words are presented to the participants.

    A questionnaire is completed.
  •   People with an ICD-10 diagnosis from the autism spectrum (Asperger's syndrome, according to ICD-10: F84.5) are included.

    Personen mit ICD-10-Diagnose aus dem Autismusspektrum (Asperger-Syndrom, nach ICD-10: F84.5) werden eingeschlossen.

    Screening tools for comparison with data collected in the study will be completed: AQ, EQ, SQ

    A general questionnaire for the collection of demographic data will be completed, as well as a screening instrument for the short recording of depressive symptoms (BDI-2).

    A verbal IQ test (WST) and a test to assess attentional load (D2) will be completed.

    A questionnaire on MRI safety is completed (applies only to the fMRI part of the study).

    Participants work on a paradigm. The participants watch short video sequences and give an assessment of the videos by button presses (in the fMRI study part, this part of the study takes place in the fMRI scanner).

    A follow-up questionnaire on the MRI experience is completed (applies only to the fMRI study part).

    Participants work on a reaction time task on the computer screen. Here, words are presented to the participants.

    A questionnaire is completed.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The evaluation of the importance of objects presented in short videos for a figure also presented depends on the gaze behaviour and language of this figure.

Primary targets:
Group mean values of the evaluation values of both groups as well as group mean values of the reaction times, as well as the corresponding individual values.

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Secondary Outcome

The assessment of the importance of objects presented in short videos for a figure also presented depends not only on the gaze behaviour and language of this figure, but also on whether the participating person has the diagnosis of an autimus spectrum disorder (Asperger's syndrome) or not.

Secondary targets:
Group mean values of the evaluation values of both groups as well as group mean values of the reaction times, as well as the corresponding individual values.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/05/13
  •   210
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- German as mother tongue, monolingual language aquisition
- right-handedness (aplies only to the fMRI study part)
- No limited vision
- No limited hearing
- Legally effective, written, declaration of consent to participate in the study


Additional inclusion criteria for people without autism spectrum disorder:
- Exclusion of neurological and psychiatric disorders
- No curret psychotropic medication or consumption of illegal substances


Additional inclusion criteria for people with autism spectrum disorder:
- Diagnosis F84.5 (Asperger syndrome) according to ICD-10
- Exclusion of comorbid neurological and psychiatric disorders (except for a depressive disorder in treatment)

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Exclusion Criteria

- minors and persons over 65 years of age
- current or previous diagnosis of psychiatric or neurological disease, but not F84.5 (Asperger's syndrome)
- limited vision
- limited hearing
- left-handedness (only in the fMRI study part)
- mother tongue other than German or bilingual language acquisition
- (possible) existing pregnancy (applies only to fMRI study part)
- metal parts (bone nails, artificial hip joints, piercings etc.) or electrical devices (e.g. cardiac pacemakers) in or on the body (only valid for fMRI study part)
- acute suicidal behavior, self-endangering or behavior that endangers others
- missing legally effective declaration of consent, persons who are not legally capable and persons in official or judicial custody (PsychKG, BTG)

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Addresses

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    • Sonderforschungsbereich 1252: Prominenz in Sprache
    • Luxemburger Str. 299
    • 50939  Köln
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. Dr.  Kai  Vogeley 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für Psychiatrie und Psychotherapie, Uniklinik Köln
    • Ms.  Juliane  Zimmermann 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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