NCT01344044

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: National Healthcare Group, Singapore · Other Government
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-05-13
• Completion: 2016-05-13
• First posted: 2011-04-28
• Last updated: 2017-03-30

Locations

1 site across 1 country: Singapore