BCI Training for Social Cognition and Error Monitoring in ASD

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder (ASD)

• Registration Number: NCT06829303
• Lead Sponsor: University of Coimbra

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Study Start: 2025-03-01
• Primary Completion: 2026-01
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to post-intervention in a computerized attention task (Subway Game)	From baseline to the end of treatment at 5 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.
Change from baseline to post-intervention in the Anxiety Sub-Scale from "The Hospital Anxiety and Depression Scale"	From baseline to the end of treatment at 5 weeks	Participants scores ranges from 0 (best outcome) to 21 (worst outcome).

Secondary Outcome Measures

Name	Time	Method
Change in error-monitoring in Emotional Facial Expression Paradigm (EFP) across intervention	At each intervention session, from first to last (intervention lasts 3 weeks and starts within 2 weeks after baseline)	Improvement of the amplitude/discrimination of waveform morphology of Event-Related Potentials (ERPs).
Change from baseline to post-intervention in the Interest/Enjoyment subscale of "Intrinsic Motivation Inventory (IMI)"	From baseline to the end of treatment at 5 weeks	Higher scores indicate greater interest/enjoyment when practicing the task (better outcome). Scores are calculated by averaging the item scores of the subscale.
Change from baseline to post-intervention in a computerized attention task (Subway Game - eye gaze)	From baseline to the end of treatment at 5 weeks,	Responses consist on the time spent to complete 3 mazes, using eye gaze. Responses are measured in seconds and the best outcomes correspond to the fastest responses.