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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Duke-NUS Graduate Medical School
Agency for Science, Technology and Research
Singapore Clinical Research Institute
Information provided by (Responsible Party):
Lim Choon Guan, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier:
NCT01344044
First received: April 27, 2011
Last updated: March 22, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Device: BCI
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of a Brain-Computer Interface Based Intervention for the Treatment of ADHD

Resource links provided by NLM:


Further study details as provided by National Healthcare Group, Singapore:

Primary Outcome Measures:
  • Attention Deficit Hyperactivity Disorder Rating Scale (ADHD Rating Scale) 4th Edition [ Time Frame: Week 0, 8, 20, 24 ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: January 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BCI treatment
BCI treatment will commence during the week of the Baseline.
Device: BCI
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
Other Name: Brain-Computer Interface
Wait-list control
BCI treatment will commence 8 weeks after Baseline
Device: BCI
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
Other Name: Brain-Computer Interface
Experimental: 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.
Device: BCI
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
Other Name: Brain-Computer Interface

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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344044

Locations
Singapore
Child Guidance Clinic, Institute of Mental Health
Singapore, Singapore
Sponsors and Collaborators
National Healthcare Group, Singapore
Duke-NUS Graduate Medical School
Agency for Science, Technology and Research
Singapore Clinical Research Institute
Investigators
Principal Investigator: Choon Guan Lim Institute of Mental Health, Singapore
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lim Choon Guan, Dr, National Healthcare Group, Singapore
ClinicalTrials.gov Identifier: NCT01344044     History of Changes
Other Study ID Numbers: DSRB Domain A/09/395 
Study First Received: April 27, 2011
Last Updated: March 22, 2016
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National Healthcare Group, Singapore:
Brain-Computer Interface

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016