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

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00723684

Purpose

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:

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

Condition	Intervention
ADHD	Other: Placebo EEG Neurofeedback Other: EEG-Neurofeedback

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	ADHD and EEG-Neurofeedback. A Double-Blind Randomized Placebo-Controlled Treatment Study.

Further study details as provided by Radboud University:

Primary Outcome Measures:

ADHD criteria according to the DSM-IV-TR rated by the investigator. [ Time Frame: before, after 10, 20, 30 sessions and after half a year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

side-effects by Score on the adapted Pittsburgh side effects rating scale [ Time Frame: before, after 10, 20, 30 sessions ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo group: Placebo Comparator This group will receive no real EEG-Neurofeedback.	Other: Placebo EEG Neurofeedback 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.
NF group: Experimental This group will receive real EEG-Neurofeedback	Other: EEG-Neurofeedback 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).

Arms

Assigned Interventions

Placebo group: Placebo Comparator

This group will receive no real EEG-Neurofeedback.

Other: Placebo EEG Neurofeedback

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.

NF group: Experimental

This group will receive real EEG-Neurofeedback

Other: EEG-Neurofeedback

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).

Eligibility

Ages Eligible for Study:	8 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723684

Contacts

Contact: J.K. Buitelaar, Professor	3613490/89 ext 024	j.buitelaar@psy.umcn.nl
Contact: M. Boomsma, MD	024352222	m.boomsma@psy.umcn.nl

Locations

Netherlands, Gelderland
Karakter Nijmegen	Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GC
Contact: M. Boomsma , MD
Principal Investigator: J.K. Buitelaar, professor
FC Donders Centre for Cognitive Neuroimaging	Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: M. Zwiers, DR. 36 10750/10651 ext 24
Sub-Investigator: M. Lansbergen, DR.

Sponsors and Collaborators

Radboud University

Investigators

Principal Investigator:

J.K. Buitelaar, Professor

UMC St. Radboud and Karakter

More Information

Responsible Party:	UMC St. Radboud ( Prof. J.K. Buitelaar )
Study ID Numbers:	NF1
Study First Received:	July 28, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00723684
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:

ADHD
Children
EEG-Neurofeedback

Study placed in the following topic categories:

Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

ClinicalTrials.gov processed this record on January 16, 2009