Attention Deficit Hyperactivity DisorderEEGNCT00802490
Effectiveness of a Electroencephalogram (EEG) Biofeedback for the Treatment of ADHD
A study testing Brain-Computer Interface System in people with Attention Deficit Hyperactivity Disorder, run by National Healthcare Group, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Brain-Computer Interface System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- May 2008to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Satisfy DSM-IV-TR criteria for ADHD (Combined OR Inattentive subtype)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Institute of Mental Health/Woodbridge Hospital
Singapore, Singapore, 539747
About this study
Official title: 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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Brain-Computer Interface System
- Keywords
- Attention Deficit Hyperactivity Disorder, Electroencephalogram biofeedback, Inattention, Brain-Computer Interface System
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Computer Interface SystemDevice
Also called Neurobiofeedback, EEG biofeedback
Newly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks.
Brain-Computer Interface SystemDevice
Newly-developed video games employing neurofeedback strategy to be played once for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 20 sessions of EEG biofeedback training Receives: Device: Brain-Computer Interface System |
| Control | Placebo comparator | Only 1 session of EEG biofeedback training Receives: Device: Brain-Computer Interface System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliable Change Index (RCI)on ADHD Rating Scale
Measured: week 0, 5, 10, 22
Secondary outcomes (1)
CBCL Attention Problem Score Change
Measured: Week 5, 10, 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Collaborators
- Institute for Infocomm Research, Duke-NUS Graduate Medical School
- Responsible party
- Principal investigator, Lim Choon Guan, National Healthcare Group, Singapore
- Investigators
- Daniel SS Fung, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802490
- Sponsor's protocol ID
- DSRB-A/07/472
- Other IDs
- NHG Grant: SIG 08/018, AV/SW/581/1107/I2R agreement
- Acronym
- EEG
- Status last verified
- Feb 2013
- First submitted
- 4 Dec 2008
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of a Brain-computer Interface System Based Programme for the Treatment of ADHD
- ClinicalTrials.gov ID
- NCT00802490
- Acronym / sponsor ID
- EEG / DSRB-A/07/472
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Electroencephalogram biofeedback, Inattention, Brain-Computer Interface System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Collaborators
- Institute for Infocomm Research, Duke-NUS Graduate Medical School
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: Brain-Computer Interface System20 sessions of EEG biofeedback training |
| Control | Placebo comparator | Device: Brain-Computer Interface SystemOnly 1 session of EEG biofeedback training |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Satisfy DSM-IV-TR criteria for ADHD (Combined OR Inattentive subtype)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain-Computer Interface SystemAlso: Neurobiofeedback, EEG biofeedbackNewly-developed video games employing neurofeedback strategy to be played twice a week, 1 hour per session for a period of ten weeks. | Device | Intervention |
| Brain-Computer Interface SystemNewly-developed video games employing neurofeedback strategy to be played once for 1 hour. | Device | Control |
Primary outcome
Reliable Change Index (RCI)on ADHD Rating Scale
Time frame: week 0, 5, 10, 22
1 secondary outcome
CBCL Attention Problem Score Change
Time frame: Week 5, 10, 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel SS Fung principal investigator
Institute of Mental Health, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-Computer Interface System in people with Attention Deficit Hyperactivity Disorder, run by National Healthcare Group, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliable Change Index (RCI)on ADHD Rating Scale (time frame: week 0, 5, 10, 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.