Идёт набор NCT06829303

BCI Training for Social Cognition and Error Monitoring in ASD

Без фазы С лечением Autism Spectrum Disorder (ASD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Emotional Facial Expression Paradigm (EFP), Speller task.
Кому может быть актуально: Состояния в реестре: Autism Spectrum Disorder (ASD). Базовые параметры: 16 лет — 55 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Португалия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Improving Social Cognition and Error Monitoring in Autism Spectrum Disorder Through a Brain Computer Interface Based on Reinforcement Learning

Обзор

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.

Вмешательства

Устройство Emotional Facial Expression Paradigm (EFP)
The experimental intervention is a social cognition gamified training, through a software that implements communication between a participant and a computer, using a detection and classification algorithm based on EEG signal. The training consists of a visual stimulation model, specifically an emotional facial paradigm, where the subject is asked to observe the movements of a facial expression (referred to as cue image) expressing either happiness or sadness and to adapt the visual gaze accordin
Устройство Speller task
The control intervention is a executive function gamified training, through a software that implements communication between a participant and a computer, using a detection and classification algorithm based on the P300 EEG signal. 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.

Первичные конечные точки

Change from baseline to post-intervention in a computerized attention task (Subway Game) [Срок оценки: From baseline to the end of treatment (maximum of 8 weeks)]
Change from baseline to post-intervention in the Anxiety Sub-Scale from "The Hospital Anxiety and Depression Scale" [Срок оценки: From baseline to the end of treatment (maximum of 8 weeks).]

Вторичные конечные точки (3)

Change in error-monitoring in Emotional Facial Expression Paradigm (EFP) across intervention [Срок оценки: 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)" [Срок оценки: 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) [Срок оценки: From baseline to the end of treatment (maximum of 8 weeks).]

Критерии участия

Критерии включения

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