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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Brain-Computer Interface System
Brain-Computer Interface System
Sponsored by
National Healthcare Group, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Electroencephalogram biofeedback, Inattention, Brain-Computer Interface System

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Mental Health/Woodbridge Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

20 sessions of EEG biofeedback training

Only 1 session of EEG biofeedback training

Outcomes

Primary Outcome Measures

Reliable Change Index (RCI)on ADHD Rating Scale

Secondary Outcome Measures

CBCL Attention Problem Score Change

Full Information

First Posted
December 4, 2008
Last Updated
February 20, 2013
Sponsor
National Healthcare Group, Singapore
Collaborators
Institute for Infocomm Research, Duke-NUS Graduate Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00802490
Brief Title
Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD
Acronym
EEG
Official Title
Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Healthcare Group, Singapore
Collaborators
Institute for Infocomm Research, Duke-NUS Graduate Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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): 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Electroencephalogram biofeedback, Inattention, Brain-Computer Interface System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
20 sessions of EEG biofeedback training
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Only 1 session of EEG biofeedback training
Intervention Type
Device
Intervention Name(s)
Brain-Computer Interface System
Other Intervention Name(s)
Neurobiofeedback, EEG biofeedback
Intervention Description
Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks.
Intervention Type
Device
Intervention Name(s)
Brain-Computer Interface System
Intervention Description
Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.
Primary Outcome Measure Information:
Title
Reliable Change Index (RCI)on ADHD Rating Scale
Time Frame
week 0, 5, 10, 22
Secondary Outcome Measure Information:
Title
CBCL Attention Problem Score Change
Time Frame
Week 5, 10, 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel SS Fung
Organizational Affiliation
Institute of Mental Health, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Mental Health/Woodbridge Hospital
City
Singapore
ZIP/Postal Code
539747
Country
Singapore

12. IPD Sharing Statement

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

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