Contact information
Type
Scientific
Primary contact
Prof Gunther Moll
ORCID ID
Contact details
University of Erlangen
Child & Adolescent Psychiatry
Schwabachanlage 6+10
Erlangen
D91054
Germany
+49 (0)913 1853 9122
Gunther.Moll@uk-erlangen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MO-726/2
Study information
Scientific title
Neurofeedback in children with attention-deficit/hyperactivity disorder: clinical efficacy and neurophysiological mechanisms
Acronym
Neurofeedback - ADHD
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Attention-deficit/hyperactivity disorder (ADHD)
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Changes from baseline to end of training in ADHD symptoms (German ADHD rating scale[FBB-HKS]).
Secondary outcome measures
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.
Overall trial start date
01/05/2005
Overall trial end date
30/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/05/2005
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Germany
Trial participating centre
University of Erlangen
Erlangen
D91054
Germany
Sponsor information
Organisation
University of Erlangen (Germany)
Sponsor details
c/o Prof. Dr. Gunther Moll
Child and Adolescent Psychiatry
Schwabachanlage 6+10
Erlangen
D 91054
Germany
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Main results
Gevensleben H, Holl B, Albrecht B, Vogel C, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H, Is neurofeedback an efficacious treatment for ADHD? A randomised controlled clinical trial., J Child Psychol Psychiatry, 2009, 50, 7, 780-789, doi: 10.1111/j.1469-7610.2008.02033.x.
-
Results on EEG effects
Gevensleben H, Holl B, Albrecht B, Schlamp D, Kratz O, Studer P, Wangler S, Rothenberger A, Moll GH, Heinrich H, Distinct EEG effects related to neurofeedback training in children with ADHD: a randomized controlled trial., Int J Psychophysiol, 2009, 74, 2, 149-157, doi: 10.1016/j.ijpsycho.2009.08.005.
-
Result
Wangler S, Gevensleben H, Albrecht B, Studer P, Rothenberger A, Moll GH, Heinrich H, Neurofeedback in children with ADHD: specific event-related potential findings of a randomized controlled trial., Clin Neurophysiol, 2011, 122, 5, 942-950, doi: 10.1016/j.clinph.2010.06.036.