Clinical trial NCT00802490: Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD
Official title: Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Electroencephalogram biofeedback
Inattention
Brain-Computer Interface System
Lead sponsor: National Healthcare Group, Singapore
Sponsor class: OTHER_GOV
Collaborators: name: Institute for Infocomm Research
name: Duke-NUS Graduate Medical School
First posted: 2008-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliable Change Index (RCI)on ADHD Rating Scale
timeFrame: week 0, 5, 10, 22
Secondary outcomes:
measure: CBCL Attention Problem Score Change
timeFrame: Week 5, 10, 22
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Institute of Mental Health/Woodbridge Hospital
Study officials:
affiliation: Institute of Mental Health, Singapore
name: Daniel SS Fung
role: PRINCIPAL_INVESTIGATOR
References: