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

Primary Purpose

Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Intervention Group
Control Group
Sponsored by
Duke-NUS Graduate Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institute of Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ADHD Rating Scale (parent)
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)
The change in the inattentive score of the ADHD RS rated by clinician and parent from week 1 to week 8.
ADHD Rating Scale
The change in parent rated ADHD-RS from week 1 to week 8.
Social Responsiveness Scale
The change in parent rated SRS from week 1 to week 8.
Clinical Global Assessment Scale (C-GAS)
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Clinical Global Impression Severity Scale (CGI-S)
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Clinical Global Impression Improvement Scale (CGI-I)
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Conners' Continuous Performance Test (CPT-II)

Full Information

First Posted
November 23, 2015
Last Updated
July 22, 2020
Sponsor
Duke-NUS Graduate Medical School
Collaborators
Institute of Mental Health, Singapore, Agency for Science, Technology and Research
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1. Study Identification

Unique Protocol Identification Number
NCT02618135
Brief Title
Brain-Computer Interface-based Programme for the Treatment of ASD/ADHD
Acronym
ASDBCI
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke-NUS Graduate Medical School
Collaborators
Institute of Mental Health, Singapore, Agency for Science, Technology and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This pilot trial aims to improve attention levels in children with comorbid ASD/ADHD. Twenty participants aged 8 to 12 years with comorbid ASD/ADHD will be recruited. Most therapy involves at least a total of 20 sessions (4); as such, the intervention protocol includes 24 sessions followed by a follow up one month after completion. The participants will attend 24 brain training sessions over an 8-week period, playing computer games designed for improving attention, facial recognition, and emotion recognition. Participants will be randomized to either the Intervention or Waitlist-Control study arm group, where the latter proceeds with training only after a wait-time of 8 weeks. The investigators hypothesize that participants in the Intervention group will show improved symptoms compared to the Waitlist-Control group at week 8. This pilot study will provide preliminary data to support the efficacy of the investigators new BCI-based training programme and potentially pave the way for a larger randomized controlled trial. Children with comorbid ASD/ADHD have greater impairments in attention, social skills and eye gaze. The investigators believe that focusing on these symptoms might lead to potentially better treatment outcomes. Also, current treatments for ASD/ADHD are limited in that they are taxing, time-consuming, and incur side effects. If the BCI-based training programme has a positive impact on children diagnosed with ASD and ADHD, it can potentially be an alternative long-term treatment. Unlike medications and behavioural interventions, neurofeedback therapy has no side effects and may be more engaging for children. It has the potential to be made available eventually for use at the patient's own home and can therefore be administered at one's own time and convenience. In 2010, the PI and his team conducted a pilot study to investigate a novel intervention for treatment of ADHD. The study involved subjects 7 to 12 years of age diagnosed with either combined or inattentive ADHD subtypes. The subjects received 20 sessions of BCI training over a 10-week period. The BCI training is an innovative design integrating neurofeedback system using an algorithm to analyze EEG brain waves, using it to drive a computer interface by sustaining a certain threshold of attention. Teachers of children in the intervention group reported larger improvements in the ADHD inattentive score although this was not statistically significant. Parents also fed back that the intervention was relatively safe to use and free of adverse effects. In 2012, the team completed another study that improved upon the technology and investigated the feasibility of the new training programme (with a simpler headset using two dry lead sensors instead of an EEG cap) on 20 unmedicated ADHD children participants. The treatment intervention was intensified to 24 sessions over 8 weeks followed by 3 monthly booster training sessions. An additional component was added to the training module where participants were required to complete a stroop task calibration process before the training. This is to personalise the intervention and improve accuracy of the EEG parameters. In this open-label trial, parents reported statistically significant improvements in both inattentive and hyperactive-impulsive symptoms on the ADHD Rating Scale at 8 weeks, which further suggests the potential efficaciousness of the novel BCI-based training programme as a potentially efficacious treatment for ADHD. In 2013, a larger-scale randomised controlled trial began to further investigate the efficacy of the BCI training on treating inattentive symptoms of ADHD. The randomized study aims to enroll 160 children between the age of 6 to 12 who will undergo 24 sessions of BCI training sessions over 8 weeks followed by 3 booster sessions. ADHD symptoms will be assessed primarily by blinded clinicians and parents as well as based on feedback obtained from respective school teachers. The study is currently ongoing and is estimated to complete by July 2016. Therapy using non-invasive BCI system-based games may represent an alternative treatment for children with ADHD and ASD. If demonstrated to be efficacious, parents are likely to prefer this as compared to current treatment modalities of medications (with potentially serious side effects) and behavior management (parents generally find this difficult and challenging). Children themselves are also more likely to enjoy the treatment and hence, comply better. In the longer term, this approach and system may have potential for attention and cognitive enhancement for patients with cognitive impairment or early dementia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention Group
Other Intervention Name(s)
BCI Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
Waitlist BCI Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
ADHD Rating Scale (clinicians)
Description
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.
Time Frame
Week 1 to Week 8
Secondary Outcome Measure Information:
Title
ADHD Rating Scale (parent)
Description
The change in the inattentive score of the ADHD RS rated by parent from week 1 to week 8.
Time Frame
Week 1 to Week 8
Title
ADHD Rating Scale (clinician and parent)
Description
The change in the inattentive score of the ADHD RS rated by clinician and parent from week 1 to week 8.
Time Frame
Week 1 to Week 8
Title
ADHD Rating Scale
Description
The change in parent rated ADHD-RS from week 1 to week 8.
Time Frame
Week 1 to Week 8
Title
Social Responsiveness Scale
Description
The change in parent rated SRS from week 1 to week 8.
Time Frame
Week 1 to Week 8
Title
Clinical Global Assessment Scale (C-GAS)
Description
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Time Frame
Week 1 to Week 8
Title
Clinical Global Impression Severity Scale (CGI-S)
Description
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Time Frame
Week 1 to Week 8
Title
Clinical Global Impression Improvement Scale (CGI-I)
Description
The change in clinician rated CGAS and CGI scores from week 1 to week 8.
Time Frame
Week 1 to Week 8
Title
Conners' Continuous Performance Test (CPT-II)
Time Frame
Week 1 to Week 8
Other Pre-specified Outcome Measures:
Title
Pediatric Adverse Event Rating Scale (PAERS)
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choon Guan Lim
Organizational Affiliation
Institute of Mental Health, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Mental Health
City
Singapore
ZIP/Postal Code
539747
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
23708709
Citation
Jang J, Matson JL, Williams LW, Tureck K, Goldin RL, Cervantes PE. 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.
Results Reference
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PubMed Identifier
20148275
Citation
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.
Results Reference
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PubMed Identifier
19856096
Citation
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.
Results Reference
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PubMed Identifier
8833315
Citation
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. Erratum In: 1996 Sep;21(3):297.
Results Reference
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PubMed Identifier
19207632
Citation
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.
Results Reference
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PubMed Identifier
20581801
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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Brain-Computer Interface-based Programme for the Treatment of ASD/ADHD

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