Trial document




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  DRKS00010091

Trial Description

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Title

Effects of transcranial electrical stimulation on the working memory and related neuronal networks in children with ADHD.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Object of investigation are the mechanisms which evoke an improvement of performance efficacy and a reduction of variability in performance when applying transcranial direct current stimulation (tDCS) in children with ADHD.
The study is investigating to which extent tDCS is able to enhance the communication of different brain areas in children with ADHD. Furthermore the study is dealing with effects of interaction of tDCS and sleep. Specifically the research project is regarding whether a stimulation prior to sleep is leading to an increased effect of a stimulation after the sleep. Moreover the study´s goal is to explore variables that predict the effects of tDCS in children with ADHD. Therefore a specified genetical and neurological inspection will be executed. Hence, the study is constituting an important empirical basis for the application of tDCS in the treatment of children with ADHD.
60 patients shall be implicated in the study: 1. 60 ADHD patients (age group 10-14)

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Brief Summary in Scientific Language

This research project on the one hand, shall investigate the underlying mechanisms that result in an improvement of cognitive performance in children and adolescents with ADHD by transcranial direct current stimulation (tDCS).
It can be assumed thattDCS above the prefrontal cortex (PFC) minimizes the ADHD-based fluctuations in connectivity and hierarchy of Resting state networks and influences the neural signature of attention positively.
On the other hand shall be investigated, which influence timing of stimulation does have on long-term after-effects of tDCS on behavioral as well as on neuro-physiological levels.
Therefore it shall be clarified whether the application of tDCS before a sleep period may lead to more pronounced after-effects than stimulation before a wake period.
And ultimately predictors for individual effects by tDCS shall be analyzed, especially genetic predisposition, Pattern of neuronal connectivity in EEG and level of synaptic excitability.

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Organizational Data

  •   DRKS00010091
  •   2016/03/11
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  •   yes
  •   Approved
  •   A130/15, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   F90.0 -  Disturbance of activity and attention
  •   F90.1 -  Hyperkinetic conduct disorder
  •   F98.8 -  Other specified behavioural and emotional disorders with onset usually occurring in childhood and adolescence
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Interventions/Observational Groups

  •   Behavioural parameters (Reaction Time, Variability , Errors)
    Error related negativity and positivity;
    Frequency -Power of theta and alpha;
    On the source level: Source-Power and Sources-Coherence.
    Group 1: tDCS stimulation (20 minutes incl. 10s raming up and down each, with a maximum intensity of 2 mA , one application per time of testing) for time points 1 (in the morning) and 2 (in the evening, same day)
  •   Behavioural parameters (Reaction Time, Variability , Errors)
    Error related negativity and positivity;
    Frequency -Power of theta and alpha;
    On the source level: Source-Power and Sources-Coherence.
    Group 2: tDCS stimulation (20 minutes incl. 10s raming up and down each, with a maximum intensity of 2 mA , one application per time of testing) for time point 1 (in the morning) and sham(placebo)-stimulation (50s incl. 10s raming up and down each, with a maximum intensity of 2 mA , one application per time of testing) for time point 2 (in the evening, same day)
  •   Behavioural parameters (Reaction Time, Variability , Errors)
    Error related negativity and positivity;
    Frequency -Power of theta and alpha;
    On the source level: Source-Power and Sources-Coherence.
    Group 3: sham(placebo)-stimulation (50s incl. 10s raming up and down each, with a maximum intensity of 2 mA , one application per time of testing) for time points 1 (in the morning) and 2 (in the evening, same day)
  •   Behavioural parameters (Reaction Time, Variability , Errors)
    Error related negativity and positivity;
    Frequency -Power of theta and alpha;
    On the source level: Source-Power and Sources-Coherence.
    Group 4: sham(placebo)-stimulation (50s incl. 10s raming up and down each, with a maximum intensity of 2 mA , one application per time of testing) for time point 1 (in the morning) and tDCS stimulation (20 minutes incl. 10s raming up and down each, with a maximum intensity of 2 mA , one application per time of testing) for time point 2 (in the evening, same day)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo, Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

On the behavioural level, reaction time, its variability, omission and commission errors will be analysed, detected during a working memory task ("n-back"-task);
Error related negativity and positivity;
Power of theta and alpha;
On the source level, the harmonic frequency will be analysed using Dynamic Imaging of Coherent Sources.
These parameters are recorded for each stimulation condition.

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Secondary Outcome

Adverse events questionnaire (1).
When: After each experimental session.

(1) C. Poreisz, K. Boros, A. Antal, W. Paulus, Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients, Brain Res Bull, 72 (2007) 208-214

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/03/15
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   10   Years
  •   14   Years
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Additional Inclusion Criteria

consent of subjects and their parents
• Age 10 - 14 years
• Male
• right handed
• diagnosis ICD-10(F90.0, F90.1 or F98.8)

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Exclusion Criteria

internal , neurological and other psychiatric disorders
• IQ < 85
• medication
• seizures ( epilepsy ) , seizures ( even once) , febrile convulsions , increased excitability of the brain ( a history of : epilepsy typical potentials or other patho - logical EEG changes )
• metal implants in the head area ( inserted into the header area metal ) : for example, Implantation of artificial cochlea ( cochlear )
• condition after head injury with loss of consciousness
• Any pre-existing condition of the heart pacemaker
• Lack of Compliance

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Addresses

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    • Institut für Medizinische Psychologie und Medizinische Soziologie, Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof.  Michael  Siniatchkin 
    • Preußerstrasse 1-9,
    • 24105  Kiel
    • Germany
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    • , Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie, Zentrum für Integrative Psychiatrie gGmbH. Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  PD.Dr  Alexander  Prehn-Kristensen 
    • Niemannsweg 147
    • D-24105  Kiel
    • Germany
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    • Institut für Medizinische Psychologie und Medizinische Soziologie, Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof.  Michael  Siniatchkin 
    • Preußerstrasse 1-9,
    • 24105  Kiel
    • Germany
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    • Institut für Medizinische Psychologie und Medizinische Soziologie, Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof.  Michael  Siniatchkin 
    • Preußerstrasse 1-9,
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Medizinische Psychologie und Medizinische Soziologie, Universitätsklinikum Schleswig-Holstein
    • Mr.  Prof. Dr.  Michael  Siniatchkin 
    • Preusserstraße 1-9,
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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