Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD

Study Overview
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Brief Summary
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The aim of this study is to investigate if electroencephalogram (EEG) biofeedback incorporating the use of video games is effective in improving inattentive symptoms in children with ADHD.

Detailed Description
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This study will enroll 20 outpatient subjects aged 7 to 12 newly diagnosed with ADHD who have never received treatment with medication. These children should have inattentive symptoms, i.e. diagnosed with combined or inattentive subtype of ADHD, and should not have any of the exclusion criteria. Based on the gender ratios from other studies, we will enroll 8 boys and 2 girls into the intervention group, giving a male:female ratio of 4:1. 10 will be in the 'intervention' group and 10 in the 'control' group. Informed consent will be obtained from the parents, and assent from the subjects, prior to any form of assessment or intervention as part of the study. INTERVENTION The 10 subjects in the intervention group will take part in a total of 20 sessions spread over a 10-week period. Each subject will first need to master a simple concentration task involving a fishing game. After this, the child will go on to play a second soccer game. Each game employs the BCI system, and is controlled by the child's concentration, which is fed to the computer via the EEG leads. The child watches the game on a computer screen. Each session may take approximately thirty minutes. The other 10 children in the comparison group will act as controls. At the clinic visit at baseline assessment, they will play the fishing game. There will be no further intervention subsequently. ASSESSMENT The following questionnaires will be administered to all subjects in both study groups at week 5, week 10, and at 3 months post-intervention (week 22): ADHD Rating Scale: parents and teachers Child Behaviour Checklist (CBCL): parents Teacher's Report Form (TRF): teachers In addition, for those subjects in the intervention group, they will be given 2 worksheets (1 Maths and 1 short comprehension exercise) at the end of the intervention during visits 2, 4, 6, 8, 10, 12, 14, 16, 18 and 20 over the 10-week period. Their EEG activity will be recorded during the completion of these worksheets.

Official Title
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Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Device: Brain-Computer Interface System
* Device: Brain-Computer Interface System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Satisfy DSM-IV-TR criteria for ADHD (Combined OR Inattentive subtype) Exclusion Criteria: Present or history of medical treatment with stimulant medication and/or Atomoxetine Co-morbid severe psychiatric condition or known sensori-neural deficit, e.g. complete blindness or deafness History of epileptic seizures Known mental retardation (i.e. IQ 70 and below) Predominantly hyperactive/impulsive subtype of ADHD

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>20 sessions of EEG biofeedback training | Device: Brain-Computer Interface System<br>* Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks.<br>* Other names: EEG biofeedback;|
| Placebo Comparator: Control<br>Only 1 session of EEG biofeedback training | Device: Brain-Computer Interface System<br>* Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliable Change Index (RCI)on ADHD Rating Scale |  | week 0, 5, 10, 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBCL Attention Problem Score Change |  | Week 5, 10, 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder, Electroencephalogram biofeedback, Inattention, Brain-Computer Interface System