Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD

National Healthcare Group, Singapore

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Device: Brain-Computer Interface System

Study type: Interventional

Funder types: Other

Identifiers

NCT00802490

AV/SW/581/1107/I2R agreement

DSRB-A/07/472

NHG Grant: SIG 08/018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

20 sessions of EEG biofeedback training

Treatment:

Device: Brain-Computer Interface System

Device: Brain-Computer Interface System

Control

Placebo Comparator group

Description:

Only 1 session of EEG biofeedback training

Treatment:

Device: Brain-Computer Interface System

Device: Brain-Computer Interface System