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Comparison of neurofeedback and computerised attention skills training in children with attention-deficit/hyperactivity disorder (ADHD)
ISRCTN ISRCTN87071503
DOI 10.1186/ISRCTN87071503
ClinicalTrials.gov identifier
EudraCT number
Public title Comparison of neurofeedback and computerised attention skills training in children with attention-deficit/hyperactivity disorder (ADHD)
Scientific title Neurofeedback in children with attention-deficit/hyperactivity disorder: clinical efficacy and neurophysiological mechanisms
Acronym Neurofeedback - ADHD
Serial number at source MO-726/2
Study hypothesis 1. Neurofeedback training is more effective than a computerised attention training in children with attention-deficit/hyperactivity disorder (ADHD)
2. Neurophysiological mechanisms of a successful neurofeedback training can be revealed (distinct patterns for different neurofeedback protocols)
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Ethics Committee of the University of Erlangen on the 29th April 2004 (ref: 3135).
Study design Randomised, controlled, multicentre clinical trial
Countries of recruitment Germany
Disease/condition/study domain Attention-deficit/hyperactivity disorder (ADHD)
Participants - inclusion criteria 1. Aged 8 - 12 years
2. Gender: both
3. Attention-deficit/hyperactivity disorder (ADHD) (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition [DSM IV] criteria: combined type or predominantly inattentive)
4. Children with the following associated disorders are allowed to participate:
4.1. Conduct disorders
4.2. Tic disorders
4.3. Emotional disorders
4.4. Dyslexia
Participants - exclusion criteria 1. Comorbid disorders other than those mentioned in the inclusion criteria
2. Gross neurological or other organic disorders
3. Pharmacological treatment or other psychotherapies
4. Intelligence quotient (IQ) less than 80
Anticipated start date 01/05/2005
Anticipated end date 30/09/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 120
Interventions Experimental intervention: neurofeedback training (comprising so-called theta/beta training and training of slow cortical potentials)
Control intervention: computerised attention skill training

Children are randomly assigned to one of the two trainings. Both trainings consist of two blocks of 18 sessions (double sessions of about 50 minutes each, separated by a short break), two to three double sessions a week. There is an intermission of about two to three weeks between the two blocks. In the training, the children develop strategies for focusing their attention and are instructed on how to practice these strategies at home and in school.
Primary outcome measure(s) Changes from baseline to end of training in ADHD symptoms (German ADHD rating scale[FBB-HKS]).
Secondary outcome measure(s) Behavioural level (parent and teacher ratings):
1. Positive and negative attributes using the Strength and Difficulties Questionnaire (SDQ-D)
2. Oppositional behaviour and delinquent and physical agression (FBB-SSSV)
3. Behaviour problems of the child in specific home situations (HSQ-D); including homework (HPC-D)

Neurophysiological level:
4. Brain electrical activity measures (electroencephalogram [EEG], event-related potentials) at rest and during computerised attention tasks

All measures are assessed at baseline, between the two training blocks and at the end of training. Behavioural measures will additionally be assessed at the six-month follow-up.
Sources of funding German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Trial website
Publications 1. 2009 main results in http://www.ncbi.nlm.nih.gov/pubmed/19207632
2. 2009 results on EEG effects in http://www.ncbi.nlm.nih.gov/pubmed/19712709
3. 2011 result in http://www.ncbi.nlm.nih.gov/pubmed/20843737
Contact name Prof  Gunther  Moll
  Address University of Erlangen
Child & Adolescent Psychiatry
Schwabachanlage 6+10
  City/town Erlangen
  Zip/Postcode D91054
  Country Germany
  Tel +49 (0)913 1853 9122
  Fax +49 (0)913 1853 9126
  Email Gunther.Moll@uk-erlangen.de
Sponsor University of Erlangen (Germany)
  Address c/o Prof. Dr. Gunther Moll
Child and Adolescent Psychiatry
Schwabachanlage 6+10
  City/town Erlangen
  Zip/Postcode D 91054
  Country Germany
  Sponsor website: http://www.klinikum.uni-erlangen.de
Date applied 31/03/2008
Last edited 04/07/2011
Date ISRCTN assigned 15/05/2008
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