An Interventional Study to Improve Social Attention in Autistic Spectrum Disorder (ASD): A Brain Computer Interface (BCI) Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- JAAT_NoFace
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Global Intelligence Quotient < 80
- •Associated medical condition such as epilepsy, neurocutaneous or other genetic syndromes, or other usual comorbidity in ASD samples
研究组 & 干预措施
BCI to train joint attention in ASD
We are using Brain Computer Interfaces implemented by EEG in 16 ASD subjects
干预措施: BCI to train joint attention in ASD (Device)
结局指标
主要结局
JAAT_NoFace
时间窗: 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
时间窗: 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.
次要结局
- ATEC - Autism Treatment Evaluation Checklist(16 weeks, and Follow-Up (6 months after intervention))
- VABS - Vineland Adaptive Behaviour Scale(16 weeks, and Follow-Up (6 months after intervention))
研究者
Miguel Castelo-Branco
MD, PhD
University of Coimbra