Trial document




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  DRKS00004680

Trial Description

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Title

Investigation of the biological basis of speech production and stuttering

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Trial Acronym

BGSS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Stuttering is a complex disorder arising from a large number of factors including genetics, neurophysiology, psychology and also environmental influences. In order to be able to handle this complexity, the present study tries to include as many factors as possible. Therefore genetic, morphological, psychological and social factors are considered to understand stuttering in a first step of the study. In addition, brain imaging techniques are included to record neurophysiological activity in the context of stuttering.
Such a comprehensive study enables researchers to get insights into the causes of stuttering and to investigate interactions between the large number of factors known to influence stuttering. Participants of the study are persons who stutter, which are contrasted with healthy participants. The main hypotheses are as follows: - variations of dopaminergic / serotonergic genes are associated with stuttering (moreover, it is investigated if these genetic variants influence stuttering via personality traits) - persons who stutter possess a more 'male' hand independent of gender (longer ring compared to index finger), which links to a higher prenatal testosterone level - the function of the basal ganglia in the brain differ compared to the control group (measured indirectly by a computer-experiment measuring basal ganglia function) - different mechanisms of the basal ganglia and speech areas of the brain can be observed in persons who stutter compared to healthy participants by appling brain imaging techniques

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Brief Summary in Scientific Language

In the present study multimethodological factors are included to better understand stuttering. In this context genetics (a focus lies on the investigation of dopaminergic genes), morphological factors, cognitive abilities and psychological factors like personality or environmental influences are considered. Moreover, in the present case/control study both persons who stutter and healthy participants participate in a brain imaging study to get insights into the working mechanisms of the brain. The main hypothesis have been mentioned in the "Brief Summary in Lay Language".

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Organizational Data

  •   DRKS00004680
  •   2013/02/07
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  •   yes
  •   Approved
  •   014/09, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   F98.5 -  Stuttering [stammering]
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Interventions/Observational Groups

  •   There are two experimental groups. The case group consists of stuttering patients. They provide in the context of the study a genetic sample, a handscan (to measure prenatal testosterone) and participate in a computer experiment (to indirectly measure basal ganglia functions). Depending on the patient's consent, persons who stutter also participate in a brain imaging study.
  •   The same experiments mentioned above are conducted with healthy participants to build a control group.
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Characteristics

  •   Non-interventional
  •   Other
  •   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

One primary outcome of the study is reached after defining the role of dopaminergic/serotonergic polymorphisms for stuttering. A further primary outcome is to clarify the role of prenatal testosterone for stuttering (2D:4D study). A further primary endpoint is the investigation of the basal ganglia and its role in stuttering in the MRI study.

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Secondary Outcome

A secondary outcome is to produce new hypothesis on candidate genes for stuttering from the results of the experiments and MRI data.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2013/03/01
  •   660
  •   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

The patient group must consist of persons who stutter. The control group consists of healthy participants.

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Exclusion Criteria

A history of psychiatric / neurological disorder (exception stuttering in the patient group)

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Addresses

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    • Institut für Psychologie, Universität Bonn
    • Mr.  PD Dr.  Christian  Montag 
    • Kaiser-Karl-Ring 9
    • 53111  Bonn
    • Germany
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    • Institut für Psychologie, Universität Bonn
    • Mr.  PD Dr.  Christian  Montag 
    • Kaiser-Karl-Ring 9
    • 53111  Bonn
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Institut für Psychologie, Universität Bonn
    • Mr.  PD Dr.  Christian  Montag 
    • Kaiser-Karl-Ring 9
    • 53111  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Psychologie, Universität Bonn
    • Mr.  PD Dr.  Christian  Montag 
    • Kaiser-Karl-Ring 9
    • 53111  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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