BCI Training for Social Cognition and Error Monitoring in ASD

NCT06829303 | Recruiting

• 2 other identifiers: CIB02ASD2022.12232.BDANA
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Change from baseline to post-intervention in a computerized attention task (Subway Game)

  Responses consist on the time spent to complete 3 mazes, using computer mouse navigation. Responses are measured in seconds and the best outcomes correspond to the fastest responses.

  From baseline to the end of treatment (maximum of 8 weeks)

• Change from baseline to post-intervention in the Anxiety Sub-Scale from "The Hospital Anxiety and Depression Scale"

  Participants scores ranges from 0 (best outcome) to 21 (worst outcome).

  From baseline to the end of treatment (maximum of 8 weeks).

Secondary Outcomes (3)

• Change in error-monitoring in Emotional Facial Expression Paradigm (EFP) across intervention

  At each intervention session, from first to last (intervention lasts up to 8 weeks and starts within 2 weeks after baseline)

• Change from baseline to post-intervention in the Interest/Enjoyment subscale of "Intrinsic Motivation Inventory (IMI)"

  From baseline to the end of treatment (maximum of 8 weeks)

• Change from baseline to post-intervention in a computerized attention task (Subway Game - eye gaze)

  From baseline to the end of treatment (maximum of 8 weeks).

Other Outcomes (6)

• Change in spelling accuracy in a Speller Task across intervention

  At each intervention session, from first to last (intervention lasts up to 8 weeks)

• Change from baseline to post-intervention in the "Autism Treatment Evaluation Checklist (ATEC)"

  From baseline to the end of treatment (maximum of 8 weeks)

• Change from baseline to post-intervention in total score of "Toronto Alexithymia Scale-20 (TAS-20)"

  From baseline to the end of treatment (maximum of 8 weeks)

Study Arms (2)

Experimental Arm

EXPERIMENTAL

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.

Device: Emotional Facial Expression Paradigm (EFP)

Control Arm

OTHER

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.

Device: Speller task

Interventions

Emotional Facial Expression Paradigm (EFP) 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.

Experimental Arm

Speller task 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.

Control Arm

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (1)

ICNAS

Coimbra, 3000 548, Portugal

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Miguel Castelo-Branco

CONTACT

+351239488510; mcbranco@fmed.uc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 17, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

PT (1)