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

This study has been completed.
Sponsor:
Collaborators:
Institute for Infocomm Research
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Lim Choon Guan, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier:
NCT00802490
First received: December 4, 2008
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder
Device: Brain-Computer Interface System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD

Resource links provided by NLM:


Further study details as provided by National Healthcare Group, Singapore:

Primary Outcome Measures:
  • Reliable Change Index (RCI)on ADHD Rating Scale [ Time Frame: week 0, 5, 10, 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CBCL Attention Problem Score Change [ Time Frame: Week 5, 10, 22 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2008
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Neurobiofeedback
  • EEG biofeedback
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 once for 1 hour.

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

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802490

Locations
Singapore
Institute of Mental Health/Woodbridge Hospital
Singapore, Singapore, 539747
Sponsors and Collaborators
National Healthcare Group, Singapore
Institute for Infocomm Research
Duke-NUS Graduate Medical School
Investigators
Principal Investigator: Daniel SS Fung Institute of Mental Health
  More Information

No publications provided

Responsible Party: Lim Choon Guan, Consultant, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier: NCT00802490     History of Changes
Other Study ID Numbers: DSRB-A/07/472, NHG Grant: SIG 08/018, AV/SW/581/1107/I2R agreement
Study First Received: December 4, 2008
Last Updated: February 20, 2013
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National Healthcare Group, Singapore:
Attention Deficit Hyperactivity Disorder
Electroencephalogram biofeedback
Inattention
Brain-Computer Interface System

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 09, 2014