Trial document




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  DRKS00015727

Trial Description

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Title

The influence of emotional stimuli on Speech production by healthy young and elderly Volunteers and Patient with Parkinson's disease - a longitudinale fMRI-study

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Trial Acronym

EMONAMING

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URL of the Trial

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Brief Summary in Lay Language

In daily interpersonal communication the processing of emotions is directly related to speech production. Therefore, the current study aims to examine the effects of emotional facial expressions on speech production using functional magnetic resonance imaging (fMRI). This method allows us to visualize brain activity during a cognitive task. We examine three different groups: healthy volunteers of age 20-30 and 60-75 years and subjects with M.Parkinson.

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Brief Summary in Scientific Language

The aim of the study is to investigate the influence of neutral and negative stimuli on speech production in healthy volunteers of age 20-30 and 60-75 years and Parkinson's subjects. The study focuses on cortical and subcortical changes through a healthy-aging effect, as well as the cerebral changes caused by M. Parkinson's Disease. Each of the three groups of subjects comprises 25 subjects, whose brain activity is measured by functional magnetic resonance imaging (fMRI) in the Neuroimaging Unit of the University of Oldenburg. During the measurements, the subjects are shown photographs of everyday objects and emotional facial expressions ("neutral" or "disgusted"). At first, the subject is presented a facial expression for the generation of emotions. Immediately following is the presentation of an everyday item, which should be named (picture naming task). This paradigm is a "dual task paradigm".

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Organizational Data

  •   DRKS00015727
  •   2019/05/29
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  •   yes
  •   Approved
  •   2018-092, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

  •   U1111-1234-1945 
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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   Healthy volunteers
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Interventions/Observational Groups

  •   The aim of the study is to investigate the influence of neutral and negative stimuli on speech production in healthy volunteers of age 20-30 and 60-75 years and Parkinson's subjects. Each of the three groups of subjects comprises 25 subjects, whose brain activity is measured by functional magnetic resonance imaging (fMRI) in the Neuroimaging Unit of the University of Oldenburg. During the measurements, the subjects are shown photographs of everyday objects and emotional facial expressions ("neutral" or "disgusted"). At first, the subject is presented a facial expression for the generation of emotions. Immediately following is the presentation of an everyday item, which should be named (picture naming task). This paradigm is a "dual task paradigm".
    The measurements will take place in the period from May to August on several days of the week between 8.00 - 16.30 o'clock. The time per participant is two hours.

    Arm 1: Young healthy volunteers
  •   Elderly healthy volunteers
  •   M. Parkinson Volunteers
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Method: functional magnetic resonance imaging (fMRI)
Brain activity during picture naming, modulated by emotional processing, as measured by fMRI

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Secondary Outcome

The linguistic utterances which are taken after the MRI scan are examined for loudness and latency.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/05/27
  •   75
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Right-handed,
first language: German,
Nobody suffered from a neurological or psychiatric disease with the exception of M. Parkinson in Arm 3

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Exclusion Criteria

left-handedness, seriousness articulation disorders, claustrophobia, regular intake of centrally active medication or drugs (exception specific treatment for M. Parkinson in Arm 3), tattoos, nonremovable piercing and MR-specific contraindications (e.g. cochlea implant or metal parts in body like retainer), pregnancy

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Addresses

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    • Universitätsklinik für Neurologie Evangelisches Krankenhaus Oldenburg
    • Steinweg 13
    • 26122  Oldenburg
    • Germany
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    • Carl von Ossietzky Universität Oldenburg
    • Mr.  Dr. med.  Peter  Sörös 
    • Heiligengeisthöfe 4
    • 26121  Oldenburg
    • Germany
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    • Carl von Ossietzky Universität Oldenburg
    • Mr.  Maximilian  Corsten 
    • Haarenstraße 56
    • 26122  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Carl von Ossietzky Universität Oldenburg
    • Ammerländer Heerstraße 114-118
    • 26129  Oldenburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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