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

Not Applicable

Completed

• Conditions: ADHD
• Interventions: Other: Placebo EEG Neurofeedback; Other: EEG-Neurofeedback

• Registration Number: NCT00723684
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-29
• Primary Completion: 2012-07
• Study Completion: 2013-02
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo EEG Neurofeedback	This group will receive no real EEG-Neurofeedback.
NF group	EEG-Neurofeedback	This group will receive real EEG-Neurofeedback

Primary Outcome Measures

Name	Time	Method
ADHD criteria according to the DSM-IV-TR rated by the investigator.	before, after 10, 20, 30 sessions and after half a year

Secondary Outcome Measures

Name	Time	Method
side-effects by Score on the adapted Pittsburgh side effects rating scale	before, after 10, 20, 30 sessions

Trial Locations

Locations (2)

Karakter Nijmegen; 🇳🇱 Nijmegen, Gelderland, Netherlands

FC Donders Centre for Cognitive Neuroimaging; 🇳🇱 Nijmegen, Gelderland, Netherlands