BCI (Brain Computer Interface) Intervention in Autism

NCT02445625 | Completed Results

• 1 other identifier: IBILI-VB-2015-01
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• ATEC - Autism Treatment Evaluation Checklist

  16 weeks, and Follow-Up (6 months after intervention)

• VABS - Vineland Adaptive Behaviour Scale

  16 weeks, and Follow-Up (6 months after intervention)

Other Outcomes (3)

• POMS - Profile of Mood States

  16 weeks plus 6 months

• HADS - Hospital Anxiety & Depression Scale

  16 weeks

• Debriefing Interview Questionnaire

  16 weeks

Study Arms (1)

BCI to train joint attention in ASD

EXPERIMENTAL

We are using Brain Computer Interfaces implemented by EEG in 16 ASD subjects

Device: BCI to train joint attention in ASD

Interventions

BCI to train joint attention in ASD DEVICE

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).

BCI to train joint attention in ASD

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Global Intelligence Quotient \< 80
• Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples

Sponsors & Collaborators

• University of Coimbra: lead

Related Publications (2)

• 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.

  PMID: 9084124 BACKGROUND

• 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.

  PMID: 30061811 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Prof. Dr. Miguel Castelo-Branco
• Organization: University of Coimbra

mcbranco@fmed.uc.pt

+351239790000

Study Officials

• Miguel S Castelo-Branco, MD, PhD.

  IBILI - Institute for Biomedical Imaging in Life Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 15, 2015
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: September 1, 2018
• Last Updated: February 18, 2019
• Results First Posted: February 18, 2019

Record last verified: 2018-12