NCT06829303 BCI Training for Social Cognition and Error Monitoring in ASD
| NCT ID | NCT06829303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Coimbra |
| Condition | Autism Spectrum Disorder (ASD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2025-03-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06829303 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 55 Years, studying Autism Spectrum Disorder (ASD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06829303 currently recruiting?
Yes, NCT06829303 is actively recruiting participants. Contact the research team at mcbranco@fmed.uc.pt for enrollment information.
Where is the NCT06829303 trial being conducted?
This trial is being conducted at Coimbra, Portugal.
Who is sponsoring the NCT06829303 clinical trial?
NCT06829303 is sponsored by University of Coimbra. The trial plans to enroll 28 participants.