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

NCT02618135 | Completed

• 1 other identifier: 2015/00841
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale (clinicians)

  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.

  Week 1 to Week 8

Secondary Outcomes (8)

• ADHD Rating Scale (parent)

  Week 1 to Week 8

• ADHD Rating Scale (clinician and parent)

  Week 1 to Week 8

• ADHD Rating Scale

  Week 1 to Week 8

• Social Responsiveness Scale

  Week 1 to Week 8

• Clinical Global Assessment Scale (C-GAS)

  Week 1 to Week 8

Other Outcomes (1)

• Pediatric Adverse Event Rating Scale (PAERS)

  Week 8

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

Intervention Group OTHER

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.

Also known as: BCI Training

Intervention Group

Control Group OTHER

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.

Also known as: Waitlist BCI Training

Control Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead
• Institute of Mental Health, Singapore: collaborator
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

Institute of Mental Health

Singapore, 539747, Singapore

Location

Related Publications (8)

• Jang J, Matson JL, Williams LW, Tureck K, Goldin RL, Cervantes PE. RETRACTED: Rates of comorbid symptoms in children with ASD, ADHD, and comorbid ASD and ADHD. Res Dev Disabil. 2013 Aug;34(8):2369-78. doi: 10.1016/j.ridd.2013.04.021. Epub 2013 May 22.

  PMID: 23708709 BACKGROUND

• Rommelse NN, Franke B, Geurts HM, Hartman CA, Buitelaar JK. Shared heritability of attention-deficit/hyperactivity disorder and autism spectrum disorder. Eur Child Adolesc Psychiatry. 2010 Mar;19(3):281-95. doi: 10.1007/s00787-010-0092-x. Epub 2010 Feb 11.

  PMID: 20148275 BACKGROUND

• Coben R, Linden M, Myers TE. Neurofeedback for autistic spectrum disorder: a review of the literature. Appl Psychophysiol Biofeedback. 2010 Mar;35(1):83-105. doi: 10.1007/s10484-009-9117-y.

  PMID: 19856096 BACKGROUND

• Linden M, Habib T, Radojevic V. A controlled study of the effects of EEG biofeedback on cognition and behavior of children with attention deficit disorder and learning disabilities. Biofeedback Self Regul. 1996 Mar;21(1):35-49. doi: 10.1007/BF02214148.

  PMID: 8833315 BACKGROUND

• Gevensleben H, Holl B, Albrecht B, Vogel C, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. Is neurofeedback an efficacious treatment for ADHD? A randomised controlled clinical trial. J Child Psychol Psychiatry. 2009 Jul;50(7):780-9. doi: 10.1111/j.1469-7610.2008.02033.x. Epub 2009 Jan 12.

  PMID: 19207632 BACKGROUND

• Lim CG, Lee TS, Guan C, Sheng Fung DS, Cheung YB, Teng SS, Zhang H, Krishnan KR. Effectiveness of a brain-computer interface based programme for the treatment of ADHD: a pilot study. Psychopharmacol Bull. 2010;43(1):73-82.

  PMID: 20581801 BACKGROUND

• Lee TS, Goh SJ, Quek SY, Phillips R, Guan C, Cheung YB, Feng L, Teng SS, Wang CC, Chin ZY, Zhang H, Ng TP, Lee J, Keefe R, Krishnan KR. A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy. PLoS One. 2013 Nov 18;8(11):e79419. doi: 10.1371/journal.pone.0079419. eCollection 2013.

  PMID: 24260218 BACKGROUND

• Jones W, Carr K, Klin A. Absence of preferential looking to the eyes of approaching adults predicts level of social disability in 2-year-old toddlers with autism spectrum disorder. Arch Gen Psychiatry. 2008 Aug;65(8):946-54. doi: 10.1001/archpsyc.65.8.946.

  PMID: 18678799 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Choon Guan Lim

  Institute of Mental Health, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: May 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: October 31, 2018
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

SG (1)