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Recruiting NCT06829303

BCI Training for Social Cognition and Error Monitoring in ASD

No phase Interventional Autism Spectrum Disorder (ASD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emotional Facial Expression Paradigm (EFP), Speller task.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder (ASD). Basic parameters: 16 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device 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 accordin
  • 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.

Primary outcome measures

  • Change from baseline to post-intervention in a computerized attention task (Subway Game) [Time frame: 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" [Time frame: From baseline to the end of treatment (maximum of 8 weeks).]
Secondary outcome measures (3)
  • Change in error-monitoring in Emotional Facial Expression Paradigm (EFP) across intervention [Time frame: 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)" [Time frame: 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) [Time frame: From baseline to the end of treatment (maximum of 8 weeks).]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Portugal · 1 center
  • ICNAS — Coimbra

Identifiers

NCT: NCT06829303 · CIB02ASD · 2022.12232.BDANA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗