Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      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: 
      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):

        1. ADHD Rating Scale: parents and teachers

        2. Child Behaviour Checklist (CBCL): parents

        3. 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.
    

Intervention name(s): Brain-Computer Interface System; Brain-Computer Interface System
Intervention type(s): Device; Device
Intervention description(s): Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks.; Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.
Other intervention name(s): Neurobiofeedback; EEG biofeedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Electroencephalogram biofeedback; Inattention; Brain-Computer Interface System