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

Attention Deficit Hyperactivity Disorder Clinical Trial

— EEG  

Official title:

Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802490
• Other study ID #: DSRB-A/07/472
• Secondary ID: NHG Grant: SIG 0
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: February 20, 2013
• Start date: May 2008
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: National Healthcare Group, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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.
• Brain-Computer Interface System
Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.

Locations

Country	Name	City	State
Singapore	Institute of Mental Health/Woodbridge Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National Healthcare Group, Singapore	Duke-NUS Graduate Medical School, Institute for Infocomm Research

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliable Change Index (RCI)on ADHD Rating Scale		week 0, 5, 10, 22	No
Secondary	CBCL Attention Problem Score Change		Week 5, 10, 22	No