Overview

This trial is active, not recruiting.

Condition attention deficit hyperactivity disorder
Treatment bci
Phase phase 2/phase 3
Sponsor National Healthcare Group, Singapore
Collaborator Duke-NUS Graduate Medical School
Start date January 2011
End date June 2016
Trial size 192 participants
Trial identifier NCT01344044, DSRB Domain A/09/395

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, we are also conducting an fMRI study involving interested participants, to elucidate the neural mechanisms underlying any behavioural improvement. This is necessary to help us gain a better picture of brain correlates related to ADHD and understand how the intervention can affect the brain.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
BCI treatment will commence during the week of the Baseline.
bci Brain-Computer Interface
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
(Other)
BCI treatment will commence 8 weeks after Baseline
bci Brain-Computer Interface
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
(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.
bci Brain-Computer Interface
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.

Primary Outcomes

Measure
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition
time frame: Week 0, 8, 20, 24

Eligibility Criteria

Male or female participants from 6 years up to 12 years old.

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

Additional Information

Official title A Randomised Controlled Trial of a Brain-Computer Interface Based Intervention for the Treatment of ADHD
Principal investigator Choon Guan Lim
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. We 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; they will undergo fMRI scan at Week 0 and 8 or Week 8 and 16. We 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by National Healthcare Group, Singapore.