Attention Deficit Hyperactivity DisorderPhase 2/3NCT01344044
Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 2/3 study testing BCI in people with Attention Deficit Hyperactivity Disorder, run by National Healthcare Group, Singapore at 1 site in Singapore.
Trial summary
This study aims to examine the efficacy of a brain-computer interface system for the treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesis is that children with ADHD receiving treatment with the BCI-based training will improve to a greater extent than the… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- BCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2011to 13 May 2016
- Phase
- Phase 2/3
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV-TR criteria for ADHD, either the combined or inattentive subtype, based on the Diagnostic Interview Schedule for Children (CDISC; Schaffer et al., 2000)
Who cannot join
- Present or history of medical treatment with stimulant medication and Atomoxetine
- Co-morbid severe psychiatric condition or known sensori-neural deficit e.g. complete blindness or deafness (such that they cannot play computer games)
- History of epileptic seizures
- Known Developmental Delay (i.e. IQ 70 and below)
- Predominantly Hyperactive/impulsive subtype of ADHD (i.e. no predominant inattentive symptoms)
- Present/history polyunsaturated fatty acids supplement intake (e.g. Omega-3 oil, flax seed oil, cod liver oil) in the past 3 months
- Present/history of traditional Chinese medicine (TCM) prescribed for treatment of attention problems in the past 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of a Brain-Computer Interface Based Intervention for the Treatment of ADHD
This study aims to examine the efficacy of a brain-computer interface system for the treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesis is that children with ADHD receiving treatment with the BCI-based training will improve to a greater extent than the control group.
Additionally, the investigators are also conducting an fMRI study involving interested participants, to elucidate the neural mechanisms underlying any behavioural improvement. This is necessary to help the investigators gain a better picture of brain correlates related to ADHD and understand how the intervention can affect the brain.
Read the detailed description
This BCI study will involve 2 phases. The first phase is a preliminary study to test the safety and effectiveness of the novel BCI device which involves newly developed dry electrode sensors and intervention game. Twenty children, aged 6-12 and diagnosed with Inattentive or Combined subtype of ADHD will be recruited for the study. This open-label, experimental arm will go through 8 weeks of BCI intervention.
The second phase will be a randomized controlled trial involving 160 children. They will be randomized into the treatment or control arm. The treatment arm will receive 8 weeks of BCI intervention, similar to the experimental arm. The other group will serve as wait-list controls.
The fMRI trial aims to examine the underlying neural processes explaining any therapeutic effects that may be seen.
The study will enroll 70 children with ADHD, aged 6-12, who are participating in the main randomized controlled trial: 40 from the BrainpalTM intervention group and 30 from the control group; participants will undergo fMRI scan at Week 0 and 8 or Week 8 and 16. The study will recruit another 30 children aged 6-12 from the community as the healthy control group, who will undergo the same imaging procedure once. The scans will involve both functional and structural imaging.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- BCI
- Keywords
- Brain-Computer Interface
- 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.
BCIDevice
Also called Brain-Computer Interface
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
| Study group | Role | What they receive |
|---|---|---|
| BCI treatment | Active comparator | BCI treatment will commence during the week of the Baseline. Receives: Device: BCI |
| Wait-list control | Other | BCI treatment will commence 8 weeks after Baseline Receives: Device: BCI |
| BCI pilot arm | Experimental | This is a experimental arm to test out the safety and effectiveness of BCI in improving ADHD symptoms. This pilot arm is necessary as the BCI device, incorporating dry electrode sensors and intervention game, is newly developed and have not been tested out in children with ADHD. This preliminary study will also allow us to test out the treatment protocol (24 sessions of BCI training over 8 weeks) to see if it is efficacious. Receives: Device: BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition
Measured: Week 0, 8, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startJan 2011
- Primary completion13 May 2016
- Study completion13 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Collaborators
- Duke-NUS Graduate Medical School, Agency for Science, Technology and Research, Singapore Clinical Research Institute
- Responsible party
- Principal investigator, Lim Choon Guan, National Healthcare Group, Singapore
- Investigators
- Choon Guan Lim, Principal investigator, Institute of Mental Health, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344044
- Sponsor's protocol ID
- DSRB Domain A/09/395
- Status last verified
- Mar 2017
- First submitted
- 27 Apr 2011
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lim CG, Soh CP, Lim SSY, Fung DSS, Guan C, Lee TS. Home-based brain-computer interface attention training program for attention deficit hyperactivity disorder: a feasibility trial. Child Adolesc Psychiatry Ment Health. 2023 Jan 25;17(1):15. doi: 10.1186/s13034-022-00539-x.
PubMed 36698168Lim CG, Lee TS, Guan C, Fung DS, Zhao Y, Teng SS, Zhang H, Krishnan KR. A brain-computer interface based attention training program for treating attention deficit hyperactivity disorder. PLoS One. 2012;7(10):e46692. doi: 10.1371/journal.pone.0046692. Epub 2012 Oct 24.
PubMed 23115630
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a Brain-Computer Interface Based Intervention for the Treatment of ADHD
- ClinicalTrials.gov ID
- NCT01344044
- Acronym / sponsor ID
- DSRB Domain A/09/395
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Brain-Computer Interface
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Collaborators
- Duke-NUS Graduate Medical School, Agency for Science, Technology and Research, Singapore Clinical Research Institute
- Study start
- Jan 2011
- Primary completion
- 13 May 2016 (actual)
- Study completion
- 13 May 2016 (actual)
- First posted
- 28 Apr 2011 (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.
This study aims to examine the efficacy of a brain-computer interface system for the treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The investigators hypothesis is that children with ADHD receiving treatment with the BCI-based training will improve to a greater extent than the control group.
Additionally, the investigators are also conducting an fMRI study involving interested participants, to elucidate the neural mechanisms underlying any behavioural improvement. This is necessary to help the investigators gain a better picture of brain correlates related to ADHD and understand how the intervention can affect the brain.
Detailed description
This BCI study will involve 2 phases. The first phase is a preliminary study to test the safety and effectiveness of the novel BCI device which involves newly developed dry electrode sensors and intervention game. Twenty children, aged 6-12 and diagnosed with Inattentive or Combined subtype of ADHD will be recruited for the study. This open-label, experimental arm will go through 8 weeks of BCI intervention.
The second phase will be a randomized controlled trial involving 160 children. They will be randomized into the treatment or control arm. The treatment arm will receive 8 weeks of BCI intervention, similar to the experimental arm. The other group will serve as wait-list controls.
The fMRI trial aims to examine the underlying neural processes explaining any therapeutic effects that may be seen.
The study will enroll 70 children with ADHD, aged 6-12, who are participating in the main randomized controlled trial: 40 from the BrainpalTM intervention group and 30 from the control group; participants will undergo fMRI scan at Week 0 and 8 or Week 8 and 16. The study will recruit another 30 children aged 6-12 from the community as the healthy control group, who will undergo the same imaging procedure once. The scans will involve both functional and structural imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BCI treatment | Active comparator | Device: BCIBCI treatment will commence during the week of the Baseline. |
| Wait-list control | Other | Device: BCIBCI treatment will commence 8 weeks after Baseline |
| BCI pilot arm | Experimental | Device: BCIThis is a experimental arm to test out the safety and effectiveness of BCI in improving ADHD symptoms. This pilot arm is necessary as the BCI device, incorporating dry electrode sensors and intervention game, is newly developed and have not been tested out in children with ADHD. This preliminary study will also allow us to test out the treatment protocol (24 sessions of BCI training over 8 weeks) to see if it is efficacious. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- DSM-IV-TR criteria for ADHD, either the combined or inattentive subtype, based on the Diagnostic Interview Schedule for Children (CDISC; Schaffer et al., 2000)
Key exclusion criteria (7 listed)
- Present or history of medical treatment with stimulant medication and Atomoxetine
- Co-morbid severe psychiatric condition or known sensori-neural deficit e.g. complete blindness or deafness (such that they cannot play computer games)
- History of epileptic seizures
- Known Developmental Delay (i.e. IQ 70 and below)
- Predominantly Hyperactive/impulsive subtype of ADHD (i.e. no predominant inattentive symptoms)
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 |
|---|---|---|
| BCIAlso: Brain-Computer Interface24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters. | Device | BCI pilot arm, BCI treatment, Wait-list control |
Primary outcome
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition
Time frame: Week 0, 8, 20, 24
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 30 Mar 2017.
- Derived from this study: PubMed 36698168Lim CG, Soh CP, Lim SSY, Fung DSS, Guan C, Lee TS. Home-based brain-computer interface attention training program for attention deficit hyperactivity disorder: a feasibility trial. Child Adolesc Psychiatry Ment Health. 2023 Jan 25;17(1):15. doi: 10.1186/s13034-022-00539-x.
- Derived from this study: PubMed 23115630Lim CG, Lee TS, Guan C, Fung DS, Zhao Y, Teng SS, Zhang H, Krishnan KR. A brain-computer interface based attention training program for treating attention deficit hyperactivity disorder. PLoS One. 2012;7(10):e46692. doi: 10.1371/journal.pone.0046692. Epub 2012 Oct 24.
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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.
Choon Guan Lim 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 Phase 2/3 study testing BCI 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 7 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 30 Mar 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition (time frame: Week 0, 8, 20, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344044, which also lists 2 linked publications.
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 30 Mar 2017.