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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised Controlled Trial of a Brain-Computer Interface Based Intervention for the Treatment of ADHD

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Device: BCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BCI treatment<br>BCI treatment will commence during the week of the Baseline. | Device: BCI<br>* 24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.<br>* Other names: Brain-Computer Interface;|
| Other: Wait-list control<br>BCI treatment will commence 8 weeks after Baseline | Device: BCI<br>* 24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.<br>* Other names: Brain-Computer Interface;|
| Experimental: BCI pilot arm<br>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. | Device: BCI<br>* 24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.<br>* Other names: Brain-Computer Interface;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition |  | Week 0, 8, 20, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain-Computer Interface