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
| Type | Name | Description |
|---|---|---|
| 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). |
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.