BCI (Brain Computer Interface) Intervention in Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Device: BCI to train joint attention in ASD

• Registration Number: NCT02445625
• Lead Sponsor: University of Coimbra

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).

Study Timeline

• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-15
• Study Start: 2016-02
• Primary Completion: 2017-11
• Study Completion: 2018-09
• Results First Submitted: 2018-10-11
• Status Verified: 2018-12
• Results First Submitted QC: 2019-02-13
• Last Update Submitted: 2019-02-13
• Results First Posted: 2019-02-18
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BCI to train joint attention in ASD	BCI to train joint attention in ASD	We are using Brain Computer Interfaces implemented by EEG in 16 ASD subjects

Primary Outcome Measures

Name	Time	Method
JAAT_NoFace	16 weeks, and 6 months after intervention	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	16 weeks, and 6 months after intervention	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

Name	Time	Method
ATEC - Autism Treatment Evaluation Checklist	16 weeks, and Follow-Up (6 months after intervention)	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	16 weeks, and Follow-Up (6 months after intervention)	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.