Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD (EEG)
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|ClinicalTrials.gov Identifier: NCT00802490|
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : February 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Device: Brain-Computer Interface System||Not Applicable|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||June 2012|
Active Comparator: Intervention
20 sessions of EEG biofeedback training
Device: Brain-Computer Interface System
Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks.
Placebo Comparator: Control
Only 1 session of EEG biofeedback training
Device: Brain-Computer Interface System
Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.
- Reliable Change Index (RCI)on ADHD Rating Scale [ Time Frame: week 0, 5, 10, 22 ]
- CBCL Attention Problem Score Change [ Time Frame: Week 5, 10, 22 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802490
|Institute of Mental Health/Woodbridge Hospital|
|Singapore, Singapore, 539747|
|Principal Investigator:||Daniel SS Fung||Institute of Mental Health, Singapore|