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

ADHD and EEG-neurofeedback. A Single-blind Randomized Placebo-controlled Treatment Study.

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.

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