Clinical trial NCT02445625: BCI (Brain Computer Interface) Intervention in Autism
Official title: An Interventional Study to Improve Social Attention in Autistic Spectrum Disorder (ASD): A Brain Computer Interface (BCI) Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: JAAT_NoFace
timeFrame: 16 weeks, and 6 months after intervention
measure: JAAT_Face
timeFrame: 16 weeks, and 6 months after intervention
Secondary outcomes:
measure: ATEC - Autism Treatment Evaluation Checklist
timeFrame: 16 weeks, and Follow-Up (6 months after intervention)
measure: VABS - Vineland Adaptive Behaviour Scale
timeFrame: 16 weeks, and Follow-Up (6 months after intervention)
Other outcomes:
measure: POMS - Profile of Mood States
timeFrame: 16 weeks plus 6 months
measure: HADS - Hospital Anxiety & Depression Scale
timeFrame: 16 weeks
measure: Debriefing Interview Questionnaire
timeFrame: 16 weeks
Locations:
Study officials:
affiliation: IBILI - Institute for Biomedical Imaging in Life Sciences
name: Miguel S Castelo-Branco, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.