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

Study Overview
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Brief Summary
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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.

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

Conditions
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ADHD

Intervention / Treatment
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* Other: Placebo EEG Neurofeedback
* Other: EEG-Neurofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>This group will receive no real EEG-Neurofeedback. | Other: Placebo EEG Neurofeedback<br>* 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.<br>|
| Experimental: NF group<br>This group will receive real EEG-Neurofeedback | Other: EEG-Neurofeedback<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side-effects by Score on the adapted Pittsburgh side effects rating scale |  | before, after 10, 20, 30 sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Children, EEG-Neurofeedback