Comparison of neurofeedback and computerised attention skills training in children with attention-deficit/hyperactivity disorder (ADHD)

ISRCTN	ISRCTN87071503
DOI	https://doi.org/10.1186/ISRCTN87071503
Protocol serial number	MO-726/2
Sponsor	University of Erlangen (Germany)
Funder	German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)

Submission date: 31/03/2008
Registration date: 15/05/2008
Last edited: 04/07/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gunther Moll
Scientific

University of Erlangen
Child & Adolescent Psychiatry
Schwabachanlage 6+10
Erlangen
D91054
Germany

Phone	+49 (0)913 1853 9122
Email	Gunther.Moll@uk-erlangen.de

Study information

Primary study design	Interventional
Study design	Randomised, controlled, multicentre clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Neurofeedback in children with attention-deficit/hyperactivity disorder: clinical efficacy and neurophysiological mechanisms
Study acronym	Neurofeedback - ADHD
Study objectives	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(s)	Ethics approval received from the Ethics Committee of the University of Erlangen on the 29th April 2004 (ref: 3135).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Changes from baseline to end of training in ADHD symptoms (German ADHD rating scale[FBB-HKS]).
Key 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.
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	01/05/2005
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

Germany

Study participating centre

University of Erlangen

Erlangen
D91054
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	main results	01/07/2009		Yes	No
Results article	results on EEG effects	01/11/2009		Yes	No
Results article	result	01/05/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes