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

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Device: Brain-Computer Interface System; Device: Brain-Computer Interface System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 539747
    • Institute of Mental Health/Woodbridge Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: EEG biofeedback; Neurobiofeedback; Device: Brain-Computer Interface System; Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.
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 twice a week, 1 hour per session for a period of ten weeks.; Other Names: EEG biofeedback; Neurobiofeedback; Device: Brain-Computer Interface System; Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reliable Change Index (RCI)on ADHD Rating Scale	week 0, 5, 10, 22

Secondary Outcome Measures

Outcome Measure	Time Frame
CBCL Attention Problem Score Change	Week 5, 10, 22

Collaborators and Investigators

• Sponsor: National Healthcare Group, Singapore
• Collaborators: Duke-NUS Graduate Medical School; Institute for Infocomm Research
• Investigators: Principal Investigator: Daniel SS Fung, Institute of Mental Health, Singapore

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Attention Deficit Hyperactivity Disorder; Inattention; Electroencephalogram biofeedback; Brain-Computer Interface System
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: DSRB-A/07/472; NHG Grant: SIG 08/018; AV/SW/581/1107/I2R agreement