Trial document





This trial has been registered retrospectively.
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  DRKS00003513

Trial Description

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Title

Does learning of self-control normalize the reward-system or error-processing in ADHD? An fMRI-ERP neurofeedback study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Although ADHD is a common disease among children and adolescents, possible causes and origins of this disease remain widely unknown. In most cases, pharmacological or psychotherapeutical treatment leads to an improvement of the core symptoms. Recent scientific findings give evidence that the differences in ADHD can possibly be assigned to specific brain areas and certain thinking processes. The process of reward-dependent learning and the involved brain areas seem to play an important role in the pathophysiology of ADHD. A change of these brain activities and thinking processes evoked by two months of either neurofeedback or emg-biofeedback training is to be reviewed within this study by using simultaneous EEG-fMRI and other neuropsychological outcome parameters. Boys and girls aged 12 to 14 diagnosed with hyperkinetic disorder according to ICD-10 criteria as well as healthy children within the same age-range can take part in the study. By using EEG we hope to assess the temporal course of information processing within the brain. fMRI is a recent imaging method which allows us to visualize and measure brain activity. The combination of EEG with fMRI indicates even more precisely, where and when activity occurs. By comparing brain activation patterns before and after the training we should be able to review the impact of the treatment.

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Brief Summary in Scientific Language

Learning mechanisms are based both on reinforcement processes as well as on cognition and motivation. Recent research indicates that patients with Attention Deficit Hyperactivity Disorder (ADHD) show a hyporesponsiveness of the reward system towards positive and negative stimuli as well as an impaired performance monitoring and cognitive control system. The proposed project will investigate the cognitive and neuronal correlates of altered/impaired reward processing and performance monitoring in ADHD using cognitive tasks, a monetary incentive functional magnetic resonance imaging (fMRI)-paradigm and an electroencephalography (EEG)-coupled error detection task in 52 patients with ADHD and 26 healthy controls. It will be studied whether operant learning of cortical self-regulation of brain electrical activity via successful neurofeed¬back-training may normalize altered reward processing and performance monitoring in those patients. In a parallelized control design, two groups of 26 of the patients matched for gender, age, IQ and ADHD severity will receive 10 sessions of neurofeedback-training or electromyographic biofeedback. It is hypothesized that successful neurofeedback is associated with a normalization of neuronal activity in brain areas that are pivotal for reward processing and performance monitoring. The project will mediate between preclinical and clinical investigations of plasticity and contribute new insights into the neural correlates of learning mechanisms, self-regulation and reward processes and in ADHD.

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Organizational Data

  •   DRKS00003513
  •   2012/02/10
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  •   yes
  •   Approved
  •   2009-339N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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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
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Interventions/Observational Groups

  •   neurofeedback (slow cortical potentials), 20 sessions with 4 subunits of training per session, duration 1 1/2 hours approximately, feedback-system by Neuroconn. Lenght of the intervention phase 10 weeks
  •   EMG-biofeedback (m. trapezius), 20 sessions with 4 subunits of training per session, duration 1 1/2 hours approximately, feedback-system by Neuroconn. Lenght of the intervention phase 10 weeks
  •   Healthy controls, no Intervention. Participation in one combined fMRI-EEG-examination (corresponding to the pre-test in the intervention group)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Results of simultaneous EEG-fMRI before and after the end oft the training-phase (20 sessions, 10 weeks), especially effects of the training on brain activation-patterns within the reward-system or error processing

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Secondary Outcome

Comparison of the results of parents and teachers reports on symptoms of hyperkinetic disorder and conduct disorder/ODD (Conners-3, long version, parents and teachers rating, DISYPS-II:FBB-ADHS, FBB-SSV) before the training and after the end of the training phase (20 sessions, 10 weeks)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/03/08
  •   78
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   14   Years
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Additional Inclusion Criteria

Patients aged 12 to 14 with either the diagnosis of hyperkinetic disorder or hyperkinetic conduct disorder (F90.0 or F90.1 according to ICD 10) sufficient knowledge of the german language
IQ>80, no other comorbidities, right handedness, no permanent dental braces or other metallic implants. Patients must be able to attend 2 training sessions a week.

For the control group: No psychiatric diagnoses, sufficient knowledge of the german language
IQ>80, right handedness, no permanent dental braces or other metallic implants.

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Exclusion Criteria

IQ<80, other medication than methylphenidate, comorbidities as e.g. depression, tourette or autism, left handedness, metallic implants within the body

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr. Dr.  Tobias  Banaschewski 
    • J5
    • 68159  Mannheim
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr.  Daniel  Brandeis 
    • J5
    • 68159  Mannheim
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters, Zentralinstitut für Seelische Gesundheit
    • Ms.  Dipl. Psych.  Sarah  Baumeister 
    • J5
    • 68159  Mannheim
    • 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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    • Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters Zentralinstitut für Seelische Gesundheit
    • Mr.  Prof. Dr. Dr.  Tobias  Banaschewski 
    • J5
    • 68159  Mannheim
    • 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.