Condition category
Mental and Behavioural Disorders
Date applied
20/01/2009
Date assigned
05/02/2009
Last edited
27/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Attention-deficit/hyperactivity disorder (ADHD) is the most common behavioral disorder of childhood. Key symptoms include impaired attention, excessive motor activity, and impulsivity. At present, drugs like methylphenidate are the preferred treatment for children who have ADHD. Among alternative treatments, Neurofeedback is a non-invasive treatment for children with ADHD. Neurofeedback is a procedure that encourages the individual to exercise a certain amount of self-control over his/her 'brainwaves' as recorded by an electroencephalogram. The aim is that the children learn how to bring their neurophysiological profile closer to that of non-ADHD children, resulting in improvements in behaviour and cognition. This study will examine how well Neurofeedback works for children with ADHD in comparison to an unspecific peripheral biofeedback treatment (muscular relaxation).

Who can participate?
Children with a clinical diagnosis of ADHD and aged between 7 and 10 years old.

What does the study involve?
Children will be randomly allocated to either an average of 25 sessions of Neurofeedback or peripheral biofeedback training in 3 months. Each session will last about 60 minutes. After a six-month period, a follow-up examination will be conducted focusing on the long-term effects.

What are the possible benefits and risks of participating?
Until now, no serious side effects of Neurofeedback or peripheral biofeedback have been reported.

Where is the study run from?
Department of Child and Adolescent, Ruhr-Universität Bochum (Germany),

When is the study starting and how long is it expected to run for?
From April 2009 to April 2012.

Who is funding the study?
The project is funded by the Deutsche Forschungsgemeinschaft (DFG), Germany.

Who is the main contact?
Prof Martin Holtmann
martin.holtmann@zi-mannheim.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Holtmann

ORCID ID

Contact details

LWL University Hospital Hamm of the Ruhr- Universität Bochum
Clinic of Child and Adolescent Psychiatry
Psychotherapy and Psychosomatic Medicine
Heithofer Allee 64
Hamm
59071
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DFG HO2503 4/1

Study information

Scientific title

Neurofeedback in children with attention deficit hyperactivity disorder (ADHD): a single-blind randomised controlled trial

Acronym

Feedback

Study hypothesis

Preliminary results indicate that neurofeedback showed specific effects on impulse control in attention deficit hyperactivity disorder (ADHD) children. Futhermore, significant improvement in behaviour, attention and intelligence quotient (IQ) was observed after neurofeedback. Despite these promising results, there is still a lack of evidence on whether the observed effects are caused specifically by this intervention and are not due to unspecific effects only. The primary objective is to investigate the effects of neurofeedback on core symptoms of ADHD.

On 14/07/2011 the overall trial end date was changed from 01/04/2011 to 01/04/2012.

Ethics approval

Ethics Committee of the Department of Medicine, Johann Wolfgang Goethe University, 08/01/2009, ref: 297/08

Study design

Single-blind randomised controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel 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

Participants will be randomly allocated to the following two groups (1:1 randomisation ratio):

Intervention group:
Neurofeedback of slow cortical potentials in addition to treatment as usual (TAU). Treatment of subjects will be performed in four trial centres. Children will attend an average of 25 sessions of neurofeedback training in 3 months. Each session is expected to last approximately 60 minutes. This will include time needed for electrode montage as well as 4 x 10 minute feedback segments.

Control group:
Peripheral electromyographic (EMG) biofeedback in addition to TAU. Children assigned to the EMG group will attend an average of 25 sessions of peripheral EMG biofeedback (muscular relaxation at different regions of the body). Duration of sessions, surface of the feedback device, reinforcement and transfer exercises will be identical to the neurofeedback setting.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in ADHD Rating Scale at pre-test, treatment phase, post-test 1, post-test 2, follow-up.

Secondary outcome measures

The following will be assessed at pre-test, post-test 1, post-test 2, follow-up:
1. Clinical Global Impressions - Severity (CGI-S) Scale (at pre-test) and Clinical Global Impressions - Improvement (CGI-I) Scale (at post-test 1, post-test 2, follow-up)
2. Resumption of medication by choice of family during follow-up (yes/no)
3. Change in neuropsychological and neurophysiological parameters

Overall trial start date

01/04/2009

Overall trial end date

01/04/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects meeting all of the following criteria will be considered for admission to the trial:
1. Both males and females, aged 7 to less than 10 years inclusive
2. Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of ADHD, combined type
3. Ability of subject to understand character and individual consequences of clinical trial
4. Written informed consent must be available before enrolment in the trial
5. For women with childbearing potential, adequate contraception

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

144

Participant exclusion criteria

1. Below IQ 80 (Culture Fair Test [CFT])
2. Bipolar disorder, psychosis, serious obsessive compulsive disorder (OCD), chronic serious tics or Tourette syndrome
3. Pharmacotherapy for severe anxiety and mood disorders and psychosis
4. Major neurological or medical illness
5. Non-German speaking child and primary caretaker
6. No telephone
7. Suicidal
8. Pregnancy and lactation
9. Participation in other clinical trials and observation period of competing trials, respectively

Recruitment start date

01/04/2009

Recruitment end date

01/04/2012

Locations

Countries of recruitment

Germany

Trial participating centre

LWL University Hospital Hamm of the Ruhr- Universität Bochum
Hamm
59071
Germany

Sponsor information

Organisation

Ruhr-Universität Bochum (Germany)

Sponsor details

Department of Child and Adolescent
Psychiatry and Psychotherapy
Postbox 102148
Bochum
44721
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.ruhr-uni-bochum.de

Funders

Funder type

Research council

Funder name

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: GZ: HO 2503/4-1)

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25123917

Publication citations

Additional files

Editorial Notes