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
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
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
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28408873