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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Healthcare Group, Singapore
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: October 29, 2013
Last verified: October 2013
  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.


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 ]

Estimated Enrollment: 180
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BCI treatment
BCI treatment
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
Device: BCI
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, after 8 weeks of study participation.
Other Name: Brain-Computer Interface
Device: BCI
Wait-list control
Wait-list control
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
Device: BCI
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, after 8 weeks of study participation.
Other Name: Brain-Computer Interface
Device: BCI
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
Device: BCI
24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, after 8 weeks of study participation.
Other Name: Brain-Computer Interface
Device: BCI

Detailed Description:

This 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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
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 Recruiting
Singapore, Singapore
Contact: Xinyi Lee       xin_yi_LEE@imh.com.sg   
Contact: Eleni Koukouna       Eleni_KOUKOUNA@imh.com.sg   
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

No publications provided by National Healthcare Group, Singapore

Additional 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: October 29, 2013
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
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014