Clinical trial NCT00723684: Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy
Official title: ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Children
EEG-Neurofeedback
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 63
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with ADHD in several mostly uncontrolled studies with relatively small sample sizes. It is unknown how EEG-neurofeedback affects brain functioning and exerts therapeutic effects in ADHD. This study is designed to examine the efficacy and safety of EEG-neurofeedback in a scientific rigorously way and to study the underlying neurobiological mechanisms of EEG-neurofeedback.

Objectives:

1. To investigate the efficacy of EEG-neurofeedback in reducing behavioral symptoms of ADHD.
2. To investigate whether EEG-neurofeedback is able to improve neurocognitive functioning.
3. To investigate whether EEG-neurofeedback is able to improve neural functioning.

Study design:

Double-blind randomized placebo-controlled treatment study.Study population: 120 subjects with ADHD (age 8-15, IQ of 80 or more). Intervention: 60 subjects with ADHD receive 30 sessions EEG-neurofeedback, and 60 subjects with ADHD receive placebo EEG-neurofeedback.

Main study parameter: ADHD-DSM-IV rating scale, rated by the investigator.

Hypothesis:

The hypothesis is EEG-Neurofeedback can reduce symptoms of ADHD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis ADHD, classified by the (Diagnostic and Statistical Manual of Mental Disorders, 2000)
* Age between 8 and 15
* A full scale IQ of more than 80
* Psychopharmaca- naïve or -free, or using a stable dosage of psychostimulants or atomoxetine but still with room for improvement (defined by an average score of more than 1 on ADHD-DSM-IV rating scale).
* Deviant EEG of more than 1.5 standard deviation compared to the database

Exclusion criteria:

* Currently intensive (i.e. weekly) individual or group psychotherapy
* Regular use of medication other than psychostimulants or atomoxetine
* Diagnosis of one or more of the following comorbid psychiatric disorders:
* Major depression
* Bipolar disorder
* Psychotic disorder
* Chronically motor tic disorder or Gilles de la Tourette
* Conduct disorder
* Autism spectrum disorders
* Eating disorders
* Neurological disorders (e.g. epilepsy) currently or in the past
* Cardiovascular disease currently or in the past
* Participation in another clinical trial simultaneously
* EEG-neurofeedback training in the past
* Use of alcohol or drugs

Primary outcomes:
measure: ADHD criteria according to the DSM-IV-TR rated by the investigator.
timeFrame: before, after 10, 20, 30 sessions and after half a year
Secondary outcomes:
measure: side-effects by Score on the adapted Pittsburgh side effects rating scale
timeFrame: before, after 10, 20, 30 sessions
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: FC Donders Centre for Cognitive Neuroimaging
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Karakter Nijmegen
state: Gelderland
Study officials:
affiliation: UMC St. Radboud and Karakter
name: J.K. Buitelaar, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vollebregt MA, van Dongen-Boomsma M, Buitelaar JK, Slaats-Willemse D. Does EEG-neurofeedback improve neurocognitive functioning in children with attention-deficit/hyperactivity disorder? A systematic review and a double-blind placebo-controlled study. J Child Psychol Psychiatry. 2014 May;55(5):460-72. doi: 10.1111/jcpp.12143. Epub 2013 Oct 30.
citation: van Dongen-Boomsma M, Vollebregt MA, Slaats-Willemse D, Buitelaar JK. A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2013 Aug;74(8):821-7. doi: 10.4088/JCP.12m08321.