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| [ Print-friendly version ] |
| Comparison of neurofeedback and computerised attention skills training in children with attention-deficit/hyperactivity disorder (ADHD) |
| ISRCTN | ISRCTN87071503 |
| ClinicalTrials.gov identifier | |
| 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) |
| 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 |
| 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 |
| 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 | 05/01/2010 |
| Date ISRCTN assigned | 15/05/2008 |
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