BCI (Brain Computer Interface) Intervention in Autism (BCIAUT)
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BCI to train joint attention in ASD
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- Positive diagnostic results for ASD in:
Autism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Exclusion Criteria:
- Global Intelligence Quotient < 80
- Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BCI to train joint attention in ASD
Arm Description
We are using Brain Computer Interfaces implemented by EEG in 16 ASD subjects
Outcomes
Primary Outcome Measures
JAAT_NoFace
Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT_NoFace with no previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.
JAAT_Face
Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT_NoFace with previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.
Secondary Outcome Measures
ATEC - Autism Treatment Evaluation Checklist
Autism Treatment Evaluation Checklist (ATEC) evaluates the effectiveness of autism treatments - a 1-page form designed to be completed by parents or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179.
The results reported here correspond to the total ATEC score to be used for comparison at a later date. The lower the score, the fewer the problems.
VABS - Vineland Adaptive Behaviour Scale
The Vineland Adaptive Behaviour Scale (VABS) is a semi-structured interview designed to assess global adaptive functioning, composed by 3 main domains: Communication COM, Daily Living Skills DLS and Socialization SOC. The Adaptive Behaviour Composite ABC (total score) is the sum of the raw scores from the main domains. These are transformed in standard scores (m.=100;std.=15). The higher the score, better is the adaptive behavior. Sparrow, S., Balla, D., & Cicchetti, D. (1984). Vineland Adaptative Behaviour Scales: Interview edition, Survey form. Circle Pines, MN: American Guidance Service.
Full Information
NCT ID
NCT02445625
First Posted
April 24, 2015
Last Updated
February 13, 2019
Sponsor
University of Coimbra
1. Study Identification
Unique Protocol Identification Number
NCT02445625
Brief Title
BCI (Brain Computer Interface) Intervention in Autism
Acronym
BCIAUT
Official Title
An Interventional Study to Improve Social Attention in Autistic Spectrum Disorder (ASD): A Brain Computer Interface (BCI) Approach
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to demonstrate that improvements in identification of social clues (and improvement of overall social behaviour) in subjects with ASD can be achieved using social games together with a BCI setup.
The primary goal is to ensure increased rate of responses to joint attention cues.
Intervention Type is a Device (brain computer interface using EEG). Structure: (1) initial eligibility screening (within 1 week after admission), (2) pre-intervention (first week of study, baseline outcome measures and additional evaluations), (3) intervention process (16 weeks), (4) post-intervention (outcome measures and additional evaluations), and (5) follow-up (outcome measures at 6 months).
Detailed Description
Clinical research has demonstrated that ASD children have deficits in the interpretation of others intentions from gaze-direction or other social attention cues (Baron-Cohen, Baldwin, & Crowson, 1997).
The purpose of the study is to investigate whether a brain computer interface (BCI) using electroencephalographic (EEG) signals can be used to train social cognition skills (in particular interpretation of gaze direction pointing to objects of interest) in ASD patients and whether this improves clinical symptoms.
The intervention comprehends seven BCI sessions spread over four months. The first four sessions are planned to occur weekly, and the rest monthly. In each session, the subject is asked to identify objects of interest based on the gaze direction of an avatar. The subject response is interpreted from the EEG signal (using the P300 component, as established in our previous work).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BCI to train joint attention in ASD
Arm Type
Experimental
Arm Description
We are using Brain Computer Interfaces implemented by EEG in 16 ASD subjects
Intervention Type
Device
Intervention Name(s)
BCI to train joint attention in ASD
Intervention Description
The intervention comprehends seven BCI sessions spread over four months. The first four sessions are planned to occur weekly, and the rest monthly. In each session, the subject is asked to identify objects of interest based on the gaze direction of an avatar. The subject response is interpreted from the EEG signal (using the P300 component, as established in our previous work).
Primary Outcome Measure Information:
Title
JAAT_NoFace
Description
Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT_NoFace with no previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.
Time Frame
16 weeks, and 6 months after intervention
Title
JAAT_Face
Description
Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT_NoFace with previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.
Time Frame
16 weeks, and 6 months after intervention
Secondary Outcome Measure Information:
Title
ATEC - Autism Treatment Evaluation Checklist
Description
Autism Treatment Evaluation Checklist (ATEC) evaluates the effectiveness of autism treatments - a 1-page form designed to be completed by parents or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179.
The results reported here correspond to the total ATEC score to be used for comparison at a later date. The lower the score, the fewer the problems.
Time Frame
16 weeks, and Follow-Up (6 months after intervention)
Title
VABS - Vineland Adaptive Behaviour Scale
Description
The Vineland Adaptive Behaviour Scale (VABS) is a semi-structured interview designed to assess global adaptive functioning, composed by 3 main domains: Communication COM, Daily Living Skills DLS and Socialization SOC. The Adaptive Behaviour Composite ABC (total score) is the sum of the raw scores from the main domains. These are transformed in standard scores (m.=100;std.=15). The higher the score, better is the adaptive behavior. Sparrow, S., Balla, D., & Cicchetti, D. (1984). Vineland Adaptative Behaviour Scales: Interview edition, Survey form. Circle Pines, MN: American Guidance Service.
Time Frame
16 weeks, and Follow-Up (6 months after intervention)
Other Pre-specified Outcome Measures:
Title
POMS - Profile of Mood States
Time Frame
16 weeks plus 6 months
Title
HADS - Hospital Anxiety & Depression Scale
Description
21-item measure of clinical depression
Time Frame
16 weeks
Title
Debriefing Interview Questionnaire
Description
Covers: strategies; general experience of the process; adverse effects;
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive diagnostic results for ASD in:
Autism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
Exclusion Criteria:
Global Intelligence Quotient < 80
Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel S Castelo-Branco, MD, PhD.
Organizational Affiliation
IBILI - Institute for Biomedical Imaging in Life Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
9084124
Citation
Baron-Cohen S, Baldwin DA, Crowson M. Do children with autism use the speaker's direction of gaze strategy to crack the code of language? Child Dev. 1997 Feb;68(1):48-57.
Results Reference
background
PubMed Identifier
30061811
Citation
Amaral C, Mouga S, Simoes M, Pereira HC, Bernardino I, Quental H, Playle R, McNamara R, Oliveira G, Castelo-Branco M. A Feasibility Clinical Trial to Improve Social Attention in Autistic Spectrum Disorder (ASD) Using a Brain Computer Interface. Front Neurosci. 2018 Jul 13;12:477. doi: 10.3389/fnins.2018.00477. eCollection 2018.
Results Reference
derived
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BCI (Brain Computer Interface) Intervention in Autism
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