Brain-Computer Interface-based Programme for the Treatment of ASD/ADHD (ASDBCI)
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ClinicalTrials.gov Identifier: NCT02618135 |
Recruitment Status :
Completed
First Posted : December 1, 2015
Last Update Posted : July 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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Attention Deficit Hyperactivity Disorder Autism Spectrum Disorders | Other: Intervention Group Other: Control Group | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual 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 |
Actual Study Start Date : | May 2016 |
Actual Primary Completion Date : | March 2018 |
Actual Study Completion Date : | October 31, 2018 |

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.
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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.
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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 |
- 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.
- 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.
- 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.
- ADHD Rating Scale [ Time Frame: Week 1 to Week 8 ]The change in parent rated ADHD-RS from week 1 to week 8.
- Social Responsiveness Scale [ Time Frame: Week 1 to Week 8 ]The change in parent rated SRS from week 1 to week 8.
- 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.
- 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.
- 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.
- Conners' Continuous Performance Test (CPT-II) [ Time Frame: Week 1 to Week 8 ]
- Pediatric Adverse Event Rating Scale (PAERS) [ Time Frame: Week 8 ]

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Ages Eligible for Study: | 8 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Co-morbid severe psychiatric condition or known sensory-neural deficit e.g. complete blindness or deafness.
- Color blindness
- History of epileptic seizures.
- Known to have developmental delay (i.e. IQ 70 and below).
- Predominantly hyperactive/impulsive subtype of ADHD.
- Change in dosage of medication (if on medication)

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
Singapore | |
Institute of Mental Health | |
Singapore, Singapore, 539747 |
Principal Investigator: | Choon Guan Lim | Institute of Mental Health, Singapore |
Responsible Party: | Lee Tih Shih, Associate Professor, Duke-NUS Graduate Medical School |
ClinicalTrials.gov Identifier: | NCT02618135 |
Other Study ID Numbers: |
2015/00841 |
First Posted: | December 1, 2015 Key Record Dates |
Last Update Posted: | July 23, 2020 |
Last Verified: | July 2020 |
Autism Spectrum Disorder Hyperkinesis Disease Attention Deficit Disorder with Hyperactivity Pathologic Processes Child Development Disorders, Pervasive |
Neurodevelopmental Disorders Mental Disorders Attention Deficit and Disruptive Behavior Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases |