BCI Training for Social Cognition and Error Monitoring in ASD (LEARNAUT)

University of Coimbra

Status: Enrolling

Conditions: Autism Spectrum Disorder (ASD)

Treatments: Device: Speller task; Device: Emotional Facial Expression Paradigm (EFP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06829303

CIB02ASD

2022.12232.BDANA (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 16 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

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.

Treatment:

Device: Emotional Facial Expression Paradigm (EFP)

Control Arm

Other group

Description:

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.

Treatment:

Device: Speller task