Condition category
Mental and Behavioural Disorders
Date applied
31/03/2008
Date assigned
15/05/2008
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.klinikum.uni-erlangen.de

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes