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

NCT ID: NCT00802490

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-06-30

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

20 sessions of EEG biofeedback training

Group Type: ACTIVE_COMPARATOR

Brain-Computer Interface System

Intervention Type: DEVICE

Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks.

Control

Only 1 session of EEG biofeedback training

Group Type: PLACEBO_COMPARATOR

Brain-Computer Interface System

Intervention Type: DEVICE

Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.

Interventions

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.

Intervention Type: DEVICE

Brain-Computer Interface System

Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.

Intervention Type: DEVICE

Other Intervention Names

Neurobiofeedback; EEG biofeedback

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Infocomm Research

OTHER

Sponsor Role: collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: collaborator

National Healthcare Group, Singapore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lim Choon Guan

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel SS Fung

Role: PRINCIPAL_INVESTIGATOR

Institute of Mental Health, Singapore

Locations

Institute of Mental Health/Woodbridge Hospital

Singapore, Singapore, Singapore

Countries

Singapore

Other Identifiers

NHG Grant: SIG 08/018

Identifier Type: -

Identifier Source: secondary_id

AV/SW/581/1107/I2R agreement

Identifier Type: -

Identifier Source: secondary_id

DSRB-A/07/472

Identifier Type: -

Identifier Source: org_study_id