Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Attention Deficit Hyperactivity Disorder |
Device: Brain-Computer Interface System |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD |
- Reliable Change Index (RCI)on ADHD Rating Scale [ Time Frame: week 0, 5, 10, 22 ] [ Designated as safety issue: No ]
- CBCL Attention Problem Score Change [ Time Frame: Week 5, 10, 22 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Names:
|
|
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.
|
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):
- 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.
Eligibility| Ages Eligible for Study: | 7 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Singapore | |
| Institute of Mental Health/Woodbridge Hospital | |
| Singapore, Singapore, 539747 | |
| Principal Investigator: | Daniel SS Fung | Institute of Mental Health |
More Information
No publications provided
| Responsible Party: | Lim Choon Guan, Consultant, National Healthcare Group, Singapore |
| ClinicalTrials.gov Identifier: | NCT00802490 History of Changes |
| Other Study ID Numbers: | DSRB-A/07/472, NHG Grant: SIG 08/018, AV/SW/581/1107/I2R agreement |
| Study First Received: | December 4, 2008 |
| Last Updated: | February 20, 2013 |
| Health Authority: | Singapore: Domain Specific Review Boards |
Keywords provided by National Healthcare Group, Singapore:
|
Attention Deficit Hyperactivity Disorder Electroencephalogram biofeedback Inattention Brain-Computer Interface System |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013