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BCI Training for Social Cognition and Error Monitoring in ASD

NCT06829303 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-08-01

No results posted yet for this study

Summary

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.

Conditions

  • Autism Spectrum Disorder (ASD)

Interventions

DEVICE

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 according the cue image.

DEVICE

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.

Sponsors & Collaborators

  • University of Coimbra

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06829303 on ClinicalTrials.gov