Project Attention Deficit Hyperactivity Disorder (ADHD) and Electroencephalography (EEG)-Neurofeedback THERapy

NCT00723684 | Completed DMC

• 1 other identifier: NF1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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

Conditions

ADHD

Keywords

ADHD; Children; EEG-Neurofeedback

Outcome Measures

Primary Outcomes (1)

• ADHD criteria according to the DSM-IV-TR rated by the investigator.

  before, after 10, 20, 30 sessions and after half a year

Secondary Outcomes (1)

• side-effects by Score on the adapted Pittsburgh side effects rating scale

  before, after 10, 20, 30 sessions

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

This group will receive no real EEG-Neurofeedback.

Other: Placebo EEG Neurofeedback

NF group

EXPERIMENTAL

This group will receive real EEG-Neurofeedback

Other: EEG-Neurofeedback

Interventions

Placebo EEG Neurofeedback OTHER

The placebo EEG-neurofeedback group will get an identical procedure as the real EEG-Neurofeedback, but with feedback on a EEG signal simulation. The placebo group will not be rewarded on their real-time EEG but on a random, simulated EEG; known to be effective for this purpose (Utrecht University, study in progress). In the protocol selection the electrode position and rewarding versus inhibition of the treatment frequency band or bands will be individually created. The first 30 seconds of the treatment will start on a predetermined fixed threshold value for all treatment subjects.

Placebo group

EEG-Neurofeedback OTHER

The EEG-neurofeedback group will receive feedback on their real-time EEG-signal (brain activity). The treatment group will be rewarded, by brightening (i.e. not being blackened of) the feedback screen. Rewards will be given to the subjects when their digitally filtered frequency EEG activity meets the criteria in the 'percentage time over threshold' parameter. The 'percentage time over threshold' parameter will be auto-adjusted on the digitally filtered real-time EEG every 30 seconds, and the percentage parameter will be kept as a constant over all participants during the entire study (i.e. not adjusted during treatment based on individual capabilities).

NF group

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (2)

FC Donders Centre for Cognitive Neuroimaging

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Karakter Nijmegen

Nijmegen, Gelderland, 6525 GC, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 24168522 DERIVED

• 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.

  PMID: 24021501 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• J.K. Buitelaar, Professor

  UMC St. Radboud and Karakter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor dr.

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 29, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: February 1, 2013
• Last Updated: March 8, 2013

Record last verified: 2013-03

Locations

NL (2)