BCI (Brain Computer Interface) Intervention in Autism (BCIAUT)

An Interventional Study to Improve Social Attention in Autistic Spectrum Disorder (ASD): A Brain Computer Interface (BCI) Approach

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).

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: BCI to train joint attention in ASD

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).

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BCI to train joint attention in ASD; We are using Brain Computer Interfaces implemented by EEG in 16 ASD subjects

Device: BCI to train joint attention in ASD; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks, and 6 months after intervention
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.	16 weeks, and 6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks, and Follow-Up (6 months after intervention)
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.	16 weeks, and Follow-Up (6 months after intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
POMS - Profile of Mood States		16 weeks plus 6 months
HADS - Hospital Anxiety & Depression Scale	21-item measure of clinical depression	16 weeks
Debriefing Interview Questionnaire	Covers: strategies; general experience of the process; adverse effects;	16 weeks

Collaborators and Investigators

• Sponsor: University of Coimbra
• Investigators: Principal Investigator: Miguel S Castelo-Branco, MD, PhD., IBILI - Institute for Biomedical Imaging in Life Sciences

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: IBILI-VB-2015-01