Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 9:06 AM
Study NCT ID:
NCT06829303
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BCI Training for Social Cognition and Error Monitoring in ASD
Sponsor:
University of Coimbra
Organization:
Study Overview
Official Title:
Improving Social Cognition and Error Monitoring in Autism Spectrum Disorder Through a Brain Computer Interface Based on Reinforcement Learning
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEARNAUT
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022.12232.BDANA | OTHER_GRANT | Fundação para a Ciência e Tecnologia (FCT) | View |