Trial document




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  DRKS00004879

Trial Description

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Title

EEG-Neurofeedbacktraining in patients with ADHD at home - Group 2: Conventional training

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Trial Acronym

NF-Home II

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URL of the Trial

http://www.meditec.hia.rwth-aachen.de/forschung/aktuelle-projekte/nf-home.html

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Brief Summary in Lay Language

EEG-based neurofeedback (NF) is an alternative option for the treatment of attention deficit hyperactivity disorder (ADHD). When using NF patients are supposed to gain regulatory control over their brain activity. However, often a significant number of training sessions is needed in order achieve symptom improvement (often > 30 sessions). In addition, improvement of training conditions is necessary, in particular such as training setups that allow training NF at home. NF-systems currently available cannot be used in home settings, have some technical disadvantages and need to be handled by trained staff. The goal of a large project is 1. to develop a new EEG-based NF-system that can be operated by lay people, and 2. the development of adapted and system-related therapy and session protocols for the use of NF at home. In the present sub-project as part of the overall project it is the aim to investigate the functionality of EEG-based NF for treatment of ADHD while using a conventional training protocol. It is the aim to recruit 20 patients with ADHD for this study. Patients will receive 20 sessions of neurofeedback-training (NFT) while using established neurofeedback devices. NF will be provided by trainers with 2 sessions per week for each subject. It is the aim of future studies to provide NFT in the home environment.

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Brief Summary in Scientific Language

EEG-based neurofeedback (NF) is an alternative option for the treatment of attention deficit hyperactivity disorder (ADHD). When using NF patients are supposed to gain regulatory control over their brain activity. However, often a significant number of training sessions is needed in order achieve symptom improvement (often > 30 sessions). In addition, improvement of training conditions is necessary, in particular such as training setups that allow training NF at home. NF-systems currently available cannot be used in home settings, have some technical disadvantages and need to be handled by trained staff. The goal of a large project is 1. to develop a new EEG-based NF-system that can be operated by lay people, and 2. the development of adapted and system-related therapy and session protocols for the use of NF at home.

In the present sub-project as part of the overall project it is the aim to investigate functionality of EEG-based NF for treatment of ADHD while using a conventional training protocol. It is the aim to recruit 20 patients with ADHD for this study. Patients will receive 20 sessions of neurofeedback-training (NFT) while using established neurofeedback devices. NF will be provided by trainers with 2 sessions per week for each subject. In order to measure symptom improvements pre- and post-training assessments comprising behavioural data and neuropsychological testing (objective computerized tasks, in particular for assessment of attentional performance) will be performed. In order to assess the stability of potential effects there will be a follow-up assessments 6 months after completion of the training sessions. It is the aim to compare the data of the present investigation with other data obtained within a study that comprised NFT delivered to young patients with ADHD by their parents whilst under supervision of a NF trainer (group 1). This particular group (group 1) received an intensive NFT with 5 sessions per week over a period of 2 weeks, followed by 2 sessions per week in a subsequent training period. Moreover, data from a further clinical group will be analysed retrospectively (outpatient NF program with NFT provide by trainers). In a further group 3 (to be studied later) NFT will be performed at home and administered to patients by their parents under supervision of a NF trainer (in accordance with the recommendations of the local ethics committee a further ethics application is planned to be submitted for this group). This group will also receive 5 NF sessions per week for 2 weeks, followed by 2 sessions per week in a subsequent training phase.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004879
  •   2013/04/25
  •   [---]*
  •   yes
  •   Approved
  •   066/13, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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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
  •   F90.8 -  Other hyperkinetic disorders
  •   F90.9 -  Hyperkinetic disorder, unspecified
  •   F98.8 -  Other specified behavioural and emotional disorders with onset usually occurring in childhood and adolescence
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Interventions/Observational Groups

  •   20 sessions of EEG-neurofeedbacktraining (2 sessions per week; duration of each session approx. 50 minutes; use of established neurofeedback devices) with trainers
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Attentional performance (to be assessed with a neuropsychological testing battery, for example subtests of the testbattery for attentional performance), measured before and after completion of trainings as well as during follow-up examination (approx. 6 months after end of trainings)

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Secondary Outcome

Clinical symptoms (Child Behavior Checklist), measured before and after completion of trainings as well as during follow-up examination (approx. 6 months after end of trainings)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/04/15
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   17   Years
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Additional Inclusion Criteria

ADHD, a combined diagnosis with conduct disorder is tolerated

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Exclusion Criteria

Epilepsy, neuroleptic medications at the time of the study, IQ below 80

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Addresses

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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum der RWTH Aachen, LFG Translationale Hirnforschung in Psychiatrie und Neurologie
    • Mr.  Prof. Dr. med., Professor als Juniorprofessor  Florian Daniel  Zepf 
    • Neuenhofer Weg 21
    • 52074  Aachen
    • Germany
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    • Hasomed GmbH
    • Paul-Ecke-Straße 1
    • 39114  Magdeburg
    • Germany
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    •   0391-6230112
    •   0391-6230113
    •   [---]*
    •   [---]*
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    • Neuroconn GmbH
    • Grenzhammer 10
    • 98693  Ilmenau
    • Germany
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    •   03677-689790
    •   03677-6897915
    •   [---]*
    •   [---]*
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    • Lehrstuhl für Medizinische Informationstechnik Helmholtz-Institut, RWTH Aachen
    • Pauwelsstr. 20
    • 52074  Aachen
    • Germany
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    •   0241-8023211
    •   0241-8082442
    •   [---]*
    •   [---]*
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    • Lehrstuhl für Medizintechnik, Helmholtz-Institut, RWTH Aachen
    • Pauwelsstr. 20
    • 52074  Aachen
    • Germany
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    •   024180-23870
    •   0241-8022870
    •   [---]*
    •   [---]*
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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum der RWTH Aachen, LFG Transnationale Hirnforschung in Psychiatrie und Neurologie
    • Mr.  Prof. Dr. med., Professor als Juniorprofessor  Florian Daniel  Zepf 
    • Neuenhofer Weg 21
    • 52074  Aachen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
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    • Klinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters, Universitätsklinikum der RWTH Aachen, LFG Translationale Hirnforschung in Psychiatrie und Neurologie
    • Ms.  Eva  Knospe 
    • Neuenhofer Weg 21
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Wirtschaft und Technologie
    • Scharnhornstr. 34-37
    • 10115  Berlin
    • Germany
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    •   030-186150
    •   030-186157010
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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