Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06829303

BCI Training for Social Cognition and Error Monitoring in ASD

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Autism Spectrum Disorder (ASD) Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

    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.

  2. 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).

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

Secondary outcomes

  1. 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)

    Improvement of the amplitude/discrimination of waveform morphology of Event-Related Potentials (ERPs).

  2. 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)

    Higher scores indicate greater interest/enjoyment when practicing the task (better outcome). Scores are calculated by averaging the item scores of the subscale.

  3. 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).

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

Other outcomes

  1. Change in spelling accuracy in a Speller Task across intervention

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

    Results consist in the spelling accuracy, i.e. correctly identified letters overall.

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

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

    The ATEC is a checklist to assess treatment effectiveness in ASD comprising 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179.

    The lower the score, the fewer the problems.

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

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

    Participants scores ranges from 20 (best outcome) to 100 (worst outcome).

  4. Change from baseline to post-intervention and across intervention in total score of "Profile of Mood State" short version (POMS)

    Time frame: From baseline to the end of treatment (maximum of 8 weeks) and across the intervention.

    Higher scores indicate a greater degree of mood disturbance.

  5. Change from baseline to post-intervention in the total score of "Anxiety Scale for Autism-Adults (ASA-A)"

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

    Participants scores ranges from 0 (best outcome) to 60 (worst outcome). A total score of ≥ 28 on the ASA-A may indicate the presence of significant levels of anxiety.

  6. Debriefing Questionnaire

    Time frame: Immediately after each intervention session

    The questionnaire will cover the participant's strategies applied on the intervention; their general experience of the intervention process; and safety assessment (adverse effects).

Study contacts

Contact information is provided by the study sponsor or research team.

Miguel Castelo-Branco

CONTACT

[email protected]

+351239488510

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Official study title

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

Acronym: LEARNAUT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.