Clinical trial NCT06829303: BCI Training for Social Cognition and Error Monitoring in ASD
Official title: Improving Social Cognition and Error Monitoring in Autism Spectrum Disorder Through a Brain Computer Interface Based on Reinforcement Learning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Lead sponsor: University of Coimbra
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to post-intervention in a computerized attention task (Subway Game)
timeFrame: From baseline to the end of treatment at 5 weeks
measure: Change from baseline to post-intervention in the Anxiety Sub-Scale from "The Hospital Anxiety and Depression Scale"
timeFrame: From baseline to the end of treatment at 5 weeks
Secondary outcomes:
measure: Change in error-monitoring in Emotional Facial Expression Paradigm (EFP) across intervention
timeFrame: At each intervention session, from first to last (intervention lasts 3 weeks and starts within 2 weeks after baseline)
measure: Change from baseline to post-intervention in the Interest/Enjoyment subscale of "Intrinsic Motivation Inventory (IMI)"
timeFrame: From baseline to the end of treatment at 5 weeks
measure: Change from baseline to post-intervention in a computerized attention task (Subway Game - eye gaze)
timeFrame: From baseline to the end of treatment at 5 weeks,
Other outcomes:
measure: Change in spelling accuracy in a Speller Task across intervention
timeFrame: At each intervention session, from first to last (intervention lasts 3 weeks and starts within 2 weeks after baseline)
measure: Change from baseline to post-intervention in the "Autism Treatment Evaluation Checklist (ATEC)"
timeFrame: From baseline to the end of treatment at 5 weeks
measure: Change from baseline to post-intervention in total score of "Toronto Alexithymia Scale-20 (TAS-20)"
timeFrame: From baseline to the end of treatment at 5 weeks
measure: Change from baseline to post-intervention and across intervention in total score of "Profile of Mood State" short version (POMS)
timeFrame: From baseline to the end of treatment at 5 weeks and across the intervention
measure: Change from baseline to post-intervention in the total score of "Anxiety Scale for Autism-Adults (ASA-A)"
timeFrame: From baseline to the end of treatment at 5 weeks.
measure: Debriefing Questionnaire
timeFrame: Immediately after each intervention session
Locations:
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