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NCT06829303Recruiting

BCI Training for Social Cognition and Error Monitoring in ASD

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

Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
28 (estimated)
First submitted
3 Feb 2025
Start date
1 Mar 2025
Primary completion date
Sept 2026
Lead sponsor
University of Coimbra
Diseases
Autism
NCT number
NCT06829303

What you commit to

  • Study type: Interventional
  • Planned participants: 28
  • From 1 Mar 2025 to the primary completion date, Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent neurofeedback therapy
  • Concomitant medication without a stable dosage for at least 4 weeks

Other illness

  • Dermatological diseases of the scalp
  • History of seizures and/or epilepsy

Other

  • Global Intelligence Quotient \<70

Who the study is looking for

  • 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

Age in the registry: 16 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ICNAS
Coordinator of this site? Confirm its status
CoimbraPortugalRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.