BCI (Brain Computer Interface) Intervention in Autism (BCIAUT)
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| ClinicalTrials.gov Identifier: NCT02445625 |
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Recruitment Status :
Completed
First Posted : May 15, 2015
Last Update Posted : September 19, 2018
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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 |
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 (Clinical Trial) |
| Actual Enrollment : | 17 participants |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: BCI to train joint attention in ASD
We are using Brain Computer Interfaces implemented by EEG in 16 ASD subjects
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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). |
- 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.
- 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
- 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;
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| Ages Eligible for Study: | 16 Years to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445625
| Principal Investigator: | Miguel S Castelo-Branco, MD, PhD. | IBILI - Institute for Biomedical Imaging in Life Sciences |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Miguel Castelo-Branco, MD, PhD, University of Coimbra |
| ClinicalTrials.gov Identifier: | NCT02445625 History of Changes |
| Other Study ID Numbers: |
IBILI-VB-2015-01 |
| First Posted: | May 15, 2015 Key Record Dates |
| Last Update Posted: | September 19, 2018 |
| Last Verified: | September 2018 |
Additional relevant MeSH terms:
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Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |