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

• ClinicalTrials.gov Identifier: NCT02445625
• Recruitment Status: Completed
• First Posted: May 15, 2015
• Results First Posted: February 18, 2019
• Last Update Posted: February 18, 2019
• Sponsor: University of Coimbra
• Information provided by (Responsible Party): Miguel Castelo-Branco, University of Coimbra

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).

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Device: BCI to train joint attention in ASD	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Interventional Study to Improve Social Attention in Autistic Spectrum Disorder (ASD): A Brain Computer Interface (BCI) Approach
• Actual Study Start Date: February 2016
• Actual Primary Completion Date: November 2017
• Actual Study Completion Date: September 2018

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. JAAT_NoFace [ Time Frame: 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.
2. JAAT_Face [ Time Frame: 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 :

1. ATEC - Autism Treatment Evaluation Checklist [ Time Frame: 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.

2. VABS - Vineland Adaptive Behaviour Scale [ Time Frame: 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.

Other Outcome Measures:

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

Eligibility Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

University of Coimbra

Investigators

• Principal Investigator: Miguel S Castelo-Branco, MD, PhD.; IBILI - Institute for Biomedical Imaging in Life Sciences

  Study Documents (Full-Text)

Documents provided by Miguel Castelo-Branco, University of Coimbra:

Statistical Analysis Plan  [PDF] February 14, 2017

Study Protocol  [PDF] June 24, 2015

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Amaral C, Mouga S, Simões 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.

• Responsible Party: Miguel Castelo-Branco, MD, PhD, University of Coimbra
• ClinicalTrials.gov Identifier: NCT02445625
• Other Study ID Numbers: IBILI-VB-2015-01
• First Posted: May 15, 2015
• Results First Posted: February 18, 2019
• Last Update Posted: February 18, 2019
• Last Verified: December 2018

Additional relevant MeSH terms:

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders