NCT01344044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2016

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

5.4 years

First QC Date

April 27, 2011

Last Update Submit

March 29, 2017

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Brain-Computer Interface

Outcome Measures

Primary Outcomes (1)

  • Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition

    Week 0, 8, 20, 24

Study Arms (3)

BCI treatment

ACTIVE COMPARATOR

BCI treatment will commence during the week of the Baseline.

Device: BCI

Wait-list control

OTHER

BCI treatment will commence 8 weeks after Baseline

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.

Device: BCI

Interventions

BCIDEVICE

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

Also known as: Brain-Computer Interface
BCI pilot armBCI treatmentWait-list control

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Guidance Clinic, Institute of Mental Health

Singapore, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 36698168DERIVED

  • 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.

    PMID: 23115630DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Choon Guan Lim

    Institute of Mental Health, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 28, 2011

Study Start

January 1, 2011

Primary Completion

May 13, 2016

Study Completion

May 13, 2016

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

SG(1)