BCI Training for Social Cognition and Error Monitoring in ASD

NCT ID: NCT06829303

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-31

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.

Conditions

Autism Spectrum Disorder (ASD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Arm

Experimental Arm The experimental group (n=17) will undergo three sessions of BCI intervention up to a maximum of six sessions. The intervention will be applied once a week, during three weeks, minimum, up to six weeks, maximum. The final number of sessions to be completed was defined after piloting. It will consist on a gamified task to train social cognition and to explore its viability for error-monitoring using EEG based non-volitional neurofeedback. The intervention comprises two modules, a visual paradigm called 'Emotional Facial Expression Paradigm' (EFP), where the subject is asked to observe the movements of a facial expression, and an 'Intelligent Agent' that learns through Reinforcement Learning from participant's judgments to the actions of the Intelligent Agent.

Group Type: EXPERIMENTAL

Emotional Facial Expression Paradigm (EFP)

Intervention Type: DEVICE

The experimental intervention is a social cognition gamified training, through a software that implements communication between a participant and a computer, using a detection and classification algorithm based on EEG signal. The training consists of a visual stimulation model, specifically an emotional facial paradigm, where the subject is asked to observe the movements of a facial expression (referred to as cue image) expressing either happiness or sadness and to adapt the visual gaze according the cue image.

Control Arm

The control group (n=17) will undergo a minimum of three and up to six sessions of BCI control intervention. The control intervention will be applied once per week. It will consist on a gamified attention task of executive function training, through a P300 BCI non-invasive interface based on EEG. The task consists of a speller, in which the participant is asked to write a word, by sequentially focusing the attention on the necessary letters.

Group Type: OTHER

Speller task

Intervention Type: DEVICE

The control intervention is a executive function gamified training, through a software that implements communication between a participant and a computer, using a detection and classification algorithm based on the P300 EEG signal. The task consists of a speller, in which the participant is asked to write a word, by sequentially focusing the attention on the necessary letters.

Interventions

Emotional Facial Expression Paradigm (EFP)

The experimental intervention is a social cognition gamified training, through a software that implements communication between a participant and a computer, using a detection and classification algorithm based on EEG signal. The training consists of a visual stimulation model, specifically an emotional facial paradigm, where the subject is asked to observe the movements of a facial expression (referred to as cue image) expressing either happiness or sadness and to adapt the visual gaze according the cue image.

Intervention Type: DEVICE

Speller task

The control intervention is a executive function gamified training, through a software that implements communication between a participant and a computer, using a detection and classification algorithm based on the P300 EEG signal. The task consists of a speller, in which the participant is asked to write a word, by sequentially focusing the attention on the necessary letters.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Miguel Castelo-Branco

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ICNAS

Coimbra, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Miguel Castelo-Branco

Role: CONTACT

mcbranco@fmed.uc.pt

+351239488510

Facility Contacts

Miguel Castelo Branco, MD PhD

Role: primary

mcbranco@fmed.uc.pt

+351936360050

Joana Amaral, MsC

Role: backup

joana.aguiar.amaral@gmail.com

Other Identifiers

2022.12232.BDANA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIB02ASD

Identifier Type: -

Identifier Source: org_study_id