Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD
| Tracking Information | |||||
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| First Received Date ICMJE | December 4, 2008 | ||||
| Last Updated Date | February 20, 2013 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reliable Change Index (RCI)on ADHD Rating Scale [ Time Frame: week 0, 5, 10, 22 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00802490 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
CBCL Attention Problem Score Change [ Time Frame: Week 5, 10, 22 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD | ||||
| Official Title ICMJE | Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD | ||||
| Brief 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. |
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| 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):
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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | June 2012 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Singapore | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00802490 | ||||
| Other Study ID Numbers ICMJE | DSRB-A/07/472, NHG Grant: SIG 08/018, AV/SW/581/1107/I2R agreement | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lim Choon Guan, National Healthcare Group, Singapore | ||||
| Study Sponsor ICMJE | National Healthcare Group, Singapore | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Healthcare Group, Singapore | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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