Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT01344044

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-05-13

Brief 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 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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BCI treatment

BCI treatment will commence during the week of the Baseline.

Group Type: ACTIVE_COMPARATOR

BCI

Intervention Type: DEVICE

24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.

Wait-list control

BCI treatment will commence 8 weeks after Baseline

Group Type: OTHER

BCI

Intervention Type: DEVICE

24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.

BCI pilot arm

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.

Group Type: EXPERIMENTAL

BCI

Intervention Type: DEVICE

24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.

Interventions

BCI

24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.

Intervention Type: DEVICE

Other Intervention Names

Brain-Computer Interface

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: collaborator

Agency for Science, Technology and Research

OTHER

Sponsor Role: collaborator

Singapore Clinical Research Institute

OTHER

Sponsor Role: collaborator

National Healthcare Group, Singapore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lim Choon Guan

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Choon Guan Lim

Role: PRINCIPAL_INVESTIGATOR

Institute of Mental Health, Singapore

Locations

Child Guidance Clinic, Institute of Mental Health

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 36698168 (View on PubMed)

Lim 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.

Reference Type: DERIVED

PMID: 23115630 (View on PubMed)

Other Identifiers

DSRB Domain A/09/395

Identifier Type: -

Identifier Source: org_study_id