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

December 4, 2008
February 20, 2013
May 2008
December 2011   (final data collection date for primary outcome measure)
Reliable Change Index (RCI)on ADHD Rating Scale [ Time Frame: week 0, 5, 10, 22 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00802490 on ClinicalTrials.gov Archive Site
CBCL Attention Problem Score Change [ Time Frame: Week 5, 10, 22 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • 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
  • Device: Brain-Computer Interface System
    Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.
  • Active Comparator: Intervention
    20 sessions of EEG biofeedback training
    Intervention: Device: Brain-Computer Interface System
  • Placebo Comparator: Control
    Only 1 session of EEG biofeedback training
    Intervention: Device: Brain-Computer Interface System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
7 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00802490
DSRB-A/07/472, NHG Grant: SIG 08/018, AV/SW/581/1107/I2R agreement
Yes
Lim Choon Guan, National Healthcare Group, Singapore
National Healthcare Group, Singapore
  • Institute for Infocomm Research
  • Duke-NUS Graduate Medical School
Principal Investigator: Daniel SS Fung Institute of Mental Health
National Healthcare Group, Singapore
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP