Clinical Trials Directory

Trials / Completed

CompletedNCT02445625

BCI (Brain Computer Interface) Intervention in Autism

An Interventional Study to Improve Social Attention in Autistic Spectrum Disorder (ASD): A Brain Computer Interface (BCI) Approach

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
University of Coimbra · Academic / Other
Sex
All
Age
16 Years – 30 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEBCI to train joint attention in ASDThe 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).

Timeline

Start date
2016-02-01
Primary completion
2017-11-01
Completion
2018-09-01
First posted
2015-05-15
Last updated
2019-02-18
Results posted
2019-02-18

Source: ClinicalTrials.gov record NCT02445625. Inclusion in this directory is not an endorsement.