Trial document




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  DRKS00008209

Trial Description

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Title

Transcranial alternating current stimulation and its influences on neurophysiological mechanisms of error processing and error regulation in healthy subjects and patients with attention deficit hyperactivity disorder (ADHD)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to gain fundamental insights into mechanism of error processing and error regulation in terms of healthy children and children with attention deficit hyperactivity disorder (ADHD).

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Brief Summary in Scientific Language

The aim of this study is to gain fundamental insights into mechanism of error processing and error regulation in terms of healthy children and children with attention deficit hyperactivity disorder (ADHD). The study offers a correlative and direct evidence for the meaning of prefrontal theta activity during performance regulation.
At first, the correlation between prefrontal theta activity after an error and the following performance is going to be examined. After that, we take a closer look at how motivational manipulation may change the outcome of the performance by using EEG. Last point of this study will be a transcranial electrical stimulation (tACS) with theta frequency to amplify the theta activity of the brain and see how this increase in theta power affects the reaction time / amount of mistakes in a continuous performance task. This study will provide an empiric basis for the application of transcranial electrical stimulation with theta frequency in the treatment of ADHD.
Subjects groups: 1. Healthy adults (Age 18-30, n=25)
2. Healthy children and adolsecnets (Age group 10-17, n=25).
3. Children and adolescents with ADHD (Age group 10-17, n=25).

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Organizational Data

  •   DRKS00008209
  •   2015/05/26
  •   [---]*
  •   yes
  •   Approved
  •   D461/15, 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
  •   Healthy Subjects
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Interventions/Observational Groups

  •   Changes after 1 mA 6 hZ for 15 min tACS over pre-supplementary motor area (pre-SMA): on the behavioural level, reaction time, its variability, omission and commission errors will be analysed;
    Error related negativity and positivity;
    Power of theta and alpha;
    On the source level, the harmonic frequency will be analyse using Dynamic Imaging of Coherent Sources.
    For subjects groups: 1. Healthy adults (Age 18-30, n=25)
    2. Healthy children and adolsecnets (Age group 10-17, n=25).
    3. Children and adolescents with ADHD (Age group 10-17, n=25).
    In each subject, the experimental sessions will be performed at the same time during the day. The duration of each experimental session is approximately 2 hours. The order between sessions will be randomized, and a break of at least seven days between experimental session.
  •   Changes after 1 mA 6 hZ for 15 min tACS over right inferior frontal gyrus (rIFG): on the behavioural level, reaction time, its variability, omission and commission errors will be analysed;
    Error related negativity and positivity;
    Power of theta and alpha;
    On the source level, the harmonic frequency will be analyse using Dynamic Imaging of Coherent Sources.
    For subjects groups: 1. Healthy adults (Age 18-30, n=25)
    2. Healthy children and adolsecnets (Age group 10-17, n=25).
    3. Children and adolescents with ADHD (Age group 10-17, n=25).
  •   Changes after 1 mA 20 hZ for 15 min tACS over rIFG: on the behavioural level, reaction time, its variability, omission and commission errors will be analysed;
    Error related negativity and positivity;
    Power of theta and alpha;
    On the source level, the harmonic frequency will be analyse using Dynamic Imaging of Coherent Sources.
    For subjects groups: 1. Healthy adults (Age 18-30, n=25)
    2. Healthy children and adolsecnets (Age group 10-17, n=25).
    3. Children and adolescents with ADHD (Age group 10-17, n=25).
  •   Changes after 1 mA Sham for 15 min tACS over pre-SMA: on the behavioural level, reaction time, its variability, omission and commission errors will be analysed;
    Error related negativity and positivity;
    Power of theta and alpha;
    On the source level, the harmonic frequency will be analyse using Dynamic Imaging of Coherent Sources.
    For subjects groups: 1. Healthy adults (Age 18-30, n=25)
    2. Healthy children and adolsecnets (Age group 10-17, n=25).
    3. Children and adolescents with ADHD (Age group 10-17, n=25).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo, Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Crossover
  •   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;
Error related negativity and positivity;
Power of theta and alpha;
On the source level, the harmonic frequency will be analyse using Dynamic Imaging of Coherent Sources.
These parameters are recorded for each stimulation condition.

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Secondary Outcome

Adverse events questionnaire (1).
Wenn: 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
  •   2015/06/01
  •   75
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   10   Years
  •   30   Years
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Additional Inclusion Criteria

• consent of subjects and their parents • Age 10 - 30 years • Male • right handed.
For patients: ICD-10(F90.0)

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Exclusion Criteria

• internal , neurological and other psychiatric disorders
• IQ < 85
• medication
• Conduct disorder
• 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, In - plantation 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 SoziologieUniversitätsklinikum Schleswig-Holstein
    • Mr.  Prof.  Michael  Siniatchkin 
    • Preußerstrasse 1-9,
    • 24105  Kiel
    • Germany
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    • Institut für Medizinische Psychologie und Medizinische SoziologieUniversitätsklinikum Schleswig-Holstein
    • Mr.  Prof.  Michael  Siniatchkin 
    • Preußerstrasse 1-9,
    • 24105  Kiel
    • Germany
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    • Institut für Medizinische Psychologie und Medizinische SoziologieUniversitätsklinikum 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 SoziologieUniversitätsklinikum Schleswig-Holstein
    • Mr.  Prof.  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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* This entry means the parameter is not applicable or has not been set.