Improving Social Cognition and Error Monitoring in Autism Spectrum Disorder Through a Brain Computer Interface Based on Reinforcement Learning
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change from baseline to post-intervention in the Anxiety Sub-Scale from "The Hospital Anxiety and Depression Scale"
研究概览
简要总结
Social cognition seems to develop atypically in autism, particularly in processes such as faces perception, joint attention and social information processing. In this sense, and using an Emotional Paradigm of Facial Expressions (EFP) with a Brain-Computer Interface (BCI) based on Electroencephalography (EEG), the investigators intend to evaluate its effectiveness as a medical device in Autism Spectrum Disorder (ASD), namely: improving 1) social skills and 2) reducing generalized anxiety, 3) improve error monitoring, and consequently verify 4) an increase in motivation. To this end, the investigators will test a gamified intervention (EFP), using personalized feedback in real time. In this gamified interface, there is an artificial agent that learns rules through Reinforcement Learning using the evoked potentials from the participant as they observe the agent's right or wrong actions. The hypothesis is that this approach allows, during the gamified task (EFP), not only the agent/interface to learn, but also the participant through operant conditioning and implicit scrutiny of errors, which makes it particularly interesting for disorders in which error monitoring processes are compromised, as in ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is able and willing to give written informed consent/assent
- •Previous diagnosis of Autism Spectrum Disorder by a qualified clinician according to gold-standard instruments
- •Aged between 16 and 55 years old
- •Normal or corrected-to-normal vision
排除标准
- •Global Intelligence Quotient <70
- •Dermatological diseases of the scalp
- •Concurrent neurofeedback therapy
- •Concomitant medication without a stable dosage for at least 4 weeks
- •History of seizures and/or epilepsy
研究组 & 干预措施
Experimental Arm
Experimental Arm The experimental group (n=17) will undergo three sessions of BCI intervention up to a maximum of six sessions. The intervention will be applied once a week, during three weeks, minimum, up to six weeks, maximum. The final number of sessions to be completed was defined after piloting. It will consist on a gamified task to train social cognition and to explore its viability for error-monitoring using EEG based non-volitional neurofeedback. The intervention comprises two modules, a visual paradigm called 'Emotional Facial Expression Paradigm' (EFP), where the subject is asked to observe the movements of a facial expression, and an 'Intelligent Agent' that learns through Reinforcement Learning from participant's judgments to the actions of the Intelligent Agent.
干预措施: Emotional Facial Expression Paradigm (EFP) (Device)
Control Arm
The control group (n=17) will undergo a minimum of three and up to six sessions of BCI control intervention. The control intervention will be applied once per week. It will consist on a gamified attention task of executive function training, through a P300 BCI non-invasive interface based on EEG. The task consists of a speller, in which the participant is asked to write a word, by sequentially focusing the attention on the necessary letters.
干预措施: Speller task (Device)
结局指标
主要结局
Change from baseline to post-intervention in the Anxiety Sub-Scale from "The Hospital Anxiety and Depression Scale"
时间窗: From baseline to the end of treatment (maximum of 8 weeks).
Participants scores ranges from 0 (best outcome) to 21 (worst outcome).
Change from baseline to post-intervention in a computerized attention task (Subway Game)
时间窗: From baseline to the end of treatment (maximum of 8 weeks)
Responses consist on the time spent to complete 3 mazes, using computer mouse navigation. Responses are measured in seconds and the best outcomes correspond to the fastest responses.
次要结局
- Change in error-monitoring in Emotional Facial Expression Paradigm (EFP) across intervention(At each intervention session, from first to last (intervention lasts up to 8 weeks and starts within 2 weeks after baseline))
- Change from baseline to post-intervention in the Interest/Enjoyment subscale of "Intrinsic Motivation Inventory (IMI)"(From baseline to the end of treatment (maximum of 8 weeks))
- Change from baseline to post-intervention in a computerized attention task (Subway Game - eye gaze)(From baseline to the end of treatment (maximum of 8 weeks).)
研究者
Miguel Castelo-Branco
MD, PhD
University of Coimbra