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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Miguel Castelo-Branco, University of Coimbra

Tracking Information
First Submitted Date  ICMJE April 24, 2015
First Posted Date  ICMJE May 15, 2015
Results First Submitted Date  ICMJE October 11, 2018
Results First Posted Date  ICMJE February 18, 2019
Last Update Posted Date February 18, 2019
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
Number of items of social attention that a patient can accurately identify in the avatar's action (e.g. looking at, pointing at) in a separate "Joint-attention task" [ Time Frame: 16 weeks ]
The group will be evaluated in the pre and post evaluation time with this test. 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. Participants will be challenged with about 20 events per minute (one every three seconds), of variable degree of difficulty. Given that the experiment lasts 10 minutes, and some events are control measures, we will have a total of 150 test events and 50 control events.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • ATEC - Autism Treatment Evaluation Checklist [ Time Frame: 16 weeks ]
    77-items: speech/language/communication (14 items); sociability (20 items); sensory/cognitive awareness (18 items); health/physical/behaviour (25 items)
  • VABS - Vineland Adaptive Behaviour Scale [ Time Frame: 16 weeks ]
    297 items measure of adaptive behaviour
Current Other Pre-specified Outcome Measures
 (submitted: February 13, 2019)
  • POMS - Profile of Mood States [ Time Frame: 16 weeks plus 6 months ]
  • HADS - Hospital Anxiety & Depression Scale [ Time Frame: 16 weeks ]
    21-item measure of clinical depression
  • Debriefing Interview Questionnaire [ Time Frame: 16 weeks ]
    Covers: strategies; general experience of the process; adverse effects;
Original Other Pre-specified Outcome Measures
 (submitted: May 14, 2015)
  • POMS - Profile of Mood States [ Time Frame: 16 weeks ]
  • HADS - Hospital Anxiety & Depression Scale [ Time Frame: 16 weeks ]
    21-item measure of clinical depression
  • Debriefing Interview Questionnaire [ Time Frame: 16 weeks ]
    Covers: strategies; general experience of the process; adverse effects;
 
Descriptive Information
Brief Title  ICMJE BCI (Brain Computer Interface) Intervention in Autism
Official Title  ICMJE An Interventional Study to Improve Social Attention in Autistic Spectrum Disorder (ASD): A Brain Computer Interface (BCI) Approach
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: BCI to train joint attention in ASD
We are using Brain Computer Interfaces implemented by EEG in 16 ASD subjects
Intervention: Device: BCI to train joint attention in ASD
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2019)
15
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2015)
16
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02445625
Other Study ID Numbers  ICMJE IBILI-VB-2015-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Miguel Castelo-Branco, University of Coimbra
Study Sponsor  ICMJE University of Coimbra
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Miguel S Castelo-Branco, MD, PhD. IBILI - Institute for Biomedical Imaging in Life Sciences
PRS Account University of Coimbra
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP