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Completed

NCT Number: NCT00802490

Effectiveness of a Electroencephalogram (EEG) Biofeedback 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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Mental Health/Woodbridge Hospital

Singapore, 539747

About this study

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):

  • ADHD Rating Scale: parents and teachers
  • Child Behaviour Checklist (CBCL): parents
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain-Computer Interface System

Device

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

Primary outcomes

  1. Reliable Change Index (RCI)on ADHD Rating Scale

    Time frame: week 0, 5, 10, 22

Secondary outcomes

  1. CBCL Attention Problem Score Change

    Time frame: Week 5, 10, 22

Sponsors and collaborators

Lead sponsor

National Healthcare Group, Singapore

Other Gov

Collaborators

  • Duke-NUS Graduate Medical School
  • Institute for Infocomm Research

Registry information

Official study title

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

Acronym: EEG

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Dec 5, 2008
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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