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Brain-Computer Interface-based Programme for the Treatment of ASD/ADHD (ASDBCI)

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ClinicalTrials.gov Identifier: NCT02618135
Recruitment Status : Unknown
Verified July 2017 by Lee Tih Shih, Duke-NUS Graduate Medical School.
Recruitment status was:  Recruiting
First Posted : December 1, 2015
Last Update Posted : August 2, 2017
Sponsor:
Collaborators:
Institute of Mental Health, Singapore
Agency for Science, Technology and Research
Information provided by (Responsible Party):
Lee Tih Shih, Duke-NUS Graduate Medical School

Brief Summary:
This project involves creating a novel and personalised BCI training system that targets social and communication difficulties, and inattentive symptoms problems often found in ASD/ADHD children. 20 participants between the age of 8 and 12 will be recruited and they will undergo 24 training sessions over an 8-week period. During these sessions, the children will play a computer game interface specifically designed to train attention and facial and emotional recognition, while using our BCI device. To further reinforce the treatment, the training system has been enhanced with the inclusion of an eye-tracker to target the lack of preferential eye contact that children with ASD exhibit. The investigators hypothesize that participants will show improvements in social skills and attention post treatment.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Autism Spectrum Disorders Other: Intervention Group Other: Control Group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Brain-Computer Interface-based Programme for the Treatment of Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder in Children: A Pilot Study
Study Start Date : May 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
10 child participants in the intervention group will take part in a total of 24 sessions spread over an 8-week period, and a final follow-up review 1 month after the completion of the training session. If sessions are missed during the 8-weeks period due to unforeseen circumstances (e.g. sickness, travel plans), arrangements will be made for participants to attend up to 5 BCI-based therapy sessions per week. All participants will have to complete a minimum of 20 sessions within the 8-weeks period for treatment efficacy.
Other: Intervention Group
Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology.
Other Name: BCI Training

Control Group
10 child participants in the control group will not receive BCI training during the first 8 weeks of their study participation; they will act as controls. At week 9, subjects in this group will go through the BCI training similar to the intervention group. If sessions are missed during the 8-weeks period due to unforeseen circumstances (e.g. sickness, travel plans), arrangements will be made for participants to attend up to 5 BCI-based therapy sessions per week. All participants will have to complete a minimum of 20 sessions within the 8-weeks period for treatment efficacy. They will take part in a total of 24 sessions spread over an 8-week period, followed by a final follow-up review 1 month after the completion of the training sessions.
Other: Control Group

Participants will wait for 8 weeks before training intervention begins.

Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology.

Other Name: Waitlist BCI Training




Primary Outcome Measures :
  1. ADHD Rating Scale (clinicians) [ Time Frame: Week 1 to Week 8 ]
    The primary outcome of this study will be the change in the inattentive score on the ADHD Rating Scale as rated by the clinicians from week 1 to week 8.


Secondary Outcome Measures :
  1. ADHD Rating Scale (parent) [ Time Frame: Week 1 to Week 8 ]
    The change in the inattentive score of the ADHD RS rated by parent from week 1 to week 8.

  2. ADHD Rating Scale (clinician and parent) [ Time Frame: Week 1 to Week 8 ]
    The change in the inattentive score of the ADHD RS rated by clinician and parent from week 1 to week 8.

  3. ADHD Rating Scale [ Time Frame: Week 1 to Week 8 ]
    The change in parent rated ADHD-RS from week 1 to week 8.

  4. Social Responsiveness Scale [ Time Frame: Week 1 to Week 8 ]
    The change in parent rated SRS from week 1 to week 8.

  5. Clinical Global Assessment Scale (C-GAS) [ Time Frame: Week 1 to Week 8 ]
    The change in clinician rated CGAS and CGI scores from week 1 to week 8.

  6. Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: Week 1 to Week 8 ]
    The change in clinician rated CGAS and CGI scores from week 1 to week 8.

  7. Clinical Global Impression Improvement Scale (CGI-I) [ Time Frame: Week 1 to Week 8 ]
    The change in clinician rated CGAS and CGI scores from week 1 to week 8.

  8. Conners' Continuous Performance Test (CPT-II) [ Time Frame: Week 1 to Week 8 ]

Other Outcome Measures:
  1. Pediatric Adverse Event Rating Scale (PAERS) [ Time Frame: Week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets diagnostic criteria for ASD, based on Autism Diagnostic Observation Scale (ADOS) and/or Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV-TR) / 5th edition (DSM 5);
  • Meets diagnostic criteria for ADHD inattentive or combined subtype, based on the Computerised Diagnostic Interview for Children (C-DISC);
  • Score 12 and above on the ADHD Rating Scale (ADHD-RS);
  • IQ above 70;
  • If on medication, dose has been stable or unchanged for at least preceding 3 months
  • Parents and teachers are English-speaking

Exclusion Criteria:

  1. Co-morbid severe psychiatric condition or known sensory-neural deficit e.g. complete blindness or deafness.
  2. Color blindness
  3. History of epileptic seizures.
  4. Known to have developmental delay (i.e. IQ 70 and below).
  5. Predominantly hyperactive/impulsive subtype of ADHD.
  6. Change in dosage of medication (if on medication)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618135


Contacts
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Contact: Tih-Shih Lee 65167461 tihshih.lee@duke-nus.edu.sg

Locations
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Singapore
Institute of Mental Health Recruiting
Singapore, Singapore, 539747
Contact: Choon Guan Lim, MBBS, M Med    6389 2200    choon_guan_lim@imh.com.sg   
Contact: Wendy Poh    6389 2200    Xue_Wei_POH@imh.com.sg   
Sponsors and Collaborators
Duke-NUS Graduate Medical School
Institute of Mental Health, Singapore
Agency for Science, Technology and Research
Investigators
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Principal Investigator: Choon Guan Lim Institute of Mental Health, Singapore

Publications:

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Responsible Party: Lee Tih Shih, Associate Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT02618135     History of Changes
Other Study ID Numbers: 2015/00841
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Child Development Disorders, Pervasive
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms