NCT00802490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

3.6 years

First QC Date

December 4, 2008

Last Update Submit

February 20, 2013

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity DisorderElectroencephalogram biofeedbackInattentionBrain-Computer Interface System

Outcome Measures

Primary Outcomes (1)

  • Reliable Change Index (RCI)on ADHD Rating Scale

    week 0, 5, 10, 22

Secondary Outcomes (1)

  • CBCL Attention Problem Score Change

    Week 5, 10, 22

Study Arms (2)

Intervention

ACTIVE COMPARATOR

20 sessions of EEG biofeedback training

Device: Brain-Computer Interface System

Control

PLACEBO COMPARATOR

Only 1 session of EEG biofeedback training

Device: Brain-Computer Interface System

Interventions

Brain-Computer Interface SystemDEVICE

Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks.

Also known as: Neurobiofeedback, EEG biofeedback
Intervention

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Satisfy DSM-IV-TR criteria for ADHD (Combined OR Inattentive subtype)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Mental Health/Woodbridge Hospital

Singapore, Singapore, 539747, Singapore

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Daniel SS Fung

    Institute of Mental Health, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 5, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

SG(1)