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| ID | Type | Description | Link |
|---|---|---|---|
| NHG Grant: SIG 08/018 | |||
| AV/SW/581/1107/I2R agreement |
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| Name | Class |
|---|---|
| Institute for Infocomm Research | OTHER |
| Duke-NUS Graduate Medical School | OTHER |
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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.
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 20 sessions of EEG biofeedback training |
|
| Control | Placebo Comparator | Only 1 session of EEG biofeedback training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain-Computer Interface System | Device | Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reliable Change Index (RCI)on ADHD Rating Scale | week 0, 5, 10, 22 |
| Measure | Description | Time Frame |
|---|---|---|
| CBCL Attention Problem Score Change | Week 5, 10, 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel SS Fung | Institute of Mental Health, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Mental Health/Woodbridge Hospital | Singapore | Singapore | 539747 | Singapore |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Brain-Computer Interface System | Device | Newly-developed video games employing neurofeedback strategy to be played once for 1 hour. |
|
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |