Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits

NCT ID: NCT05501405

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2025-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Disorders in the recognition of emotional facial expressions are part of the social cognition disorders described in several diseases. They are notably present in a quasi-systematic way in diseases associated with socio-emotional behavior disorders, such as schizophrenia and autism. They are also found in some genetic syndromes with atypical neurodevelopment. In previous studies, the investigators adopted the FPVS-EEG approach to investigate facial emotion discrimination abilities in typical and atypical developing populations. the investigatorshave shown that, in typical adults, the neural response to facial expressions emerges as emotional intensity parametrically increases. A time-domain analysis revealed three components, with the first two increasing linearly with expressive intensity, and the third (beyond 300 ms) showing categorical sensitivity to increasing expressive intensity. The investigators have already successfully extended this approach to the investigation of patients, such as those with 22q11.2 syndrome. The brain response to facial expression was reduced by approximately 36% in these patients, revealing impaired visual coding of emotional facial signals. In this study, response amplitude was associated with positive symptom severity, indicating a potential endophenotype for psychosis risk. Here, the investigators study the implementation of high-level processes and the top-down effect it should have on the response of occipitotemporal regions to identify altered brain markers in schizophrenic patients, but also in other populations with expression recognition deficits (autistic, 22q11.2, in particular). The implementation of compensatory strategies that should result in an increased exploration of the lower part of the face at the oculometric level will also be studied.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Disorders in the recognition of emotional facial expressions are part of the social cognition disorders described in several pathologies. In particular, they are almost systematically present in pathologies associated with socio-emotional behavior disorders, such as schizophrenia and autism. They are also found in certain genetic pathologies with atypical neurodevelopment .

Recently, it has been suggested to use a new approach to better understand the brain specificity of populations with face recognition difficulties: the Fast Periodic Visual Stimulation (FPVS) approach coupled with electroencephalography (FPVS-EEG) . This has been done successfully for Autism Spectrum Disorder. The investigators have also done this for 22q11.2 syndrome . This approach has proven to be particularly well suited to the study of atypical populations. However, studies to date have investigated the implicit processing of emotional facial expression. The role of top-down mechanisms related to the task remains to be studied.

Moreover, in these different diseases, difficulties in facial emotion recognition are furthermore associated with abnormalities in the visual exploration of facial features. Some profiles (looking at the lower part) might reflect compensatory strategies to compensate for difficulties in perceiving the whole face or the upper part (i.e., the eye region). Other patterns (disorganized exploration) could reflect the prevalence of psychotic signs.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Psychotic Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Brain and eyetracking markers of deficits in recognition of emotional facial expression and associated autistic and/or psychotic disorders
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Schizophrenic patients

Electroencephalogram and eye-tracking recordings Behavorial tests

Group Type EXPERIMENTAL

Electroencephalogram and eye-tracking recordings

Intervention Type OTHER

Participants will perform two tasks: recognize the expression (explicit recognition of the expression) or detect the change in color of the cross (implicit processing of the expression). Each participant will perform two tasks x 6 models x 5 expressions, i.e. 60 stimulations, for a stimulation duration of approximately 30 minutes.

Recognition of the emotional facial expression with a choice among 5 possibilities. Two neutral faces of the same person will be presented side by side. When the participant has looked at the central fixation cross for one second, one of the two faces will produce an expression. The participant will have to indicate as quickly as possible which expression it is, while his or her eye movements are recorded. Each participant will have to recognize 5 expressions x 8 models, i.e. 40 trials for a duration of approximately 5 to 10 minutes

Autism Spectrum Disorder (ASD) patients

Electroencephalogram and eye-tracking recordings

Group Type EXPERIMENTAL

Electroencephalogram and eye-tracking recordings

Intervention Type OTHER

Participants will perform two tasks: recognize the expression (explicit recognition of the expression) or detect the change in color of the cross (implicit processing of the expression). Each participant will perform two tasks x 6 models x 5 expressions, i.e. 60 stimulations, for a stimulation duration of approximately 30 minutes.

Recognition of the emotional facial expression with a choice among 5 possibilities. Two neutral faces of the same person will be presented side by side. When the participant has looked at the central fixation cross for one second, one of the two faces will produce an expression. The participant will have to indicate as quickly as possible which expression it is, while his or her eye movements are recorded. Each participant will have to recognize 5 expressions x 8 models, i.e. 40 trials for a duration of approximately 5 to 10 minutes

22q11.2 DS patients

Electroencephalogram and eye-tracking recordings Behavorial tests

Group Type EXPERIMENTAL

Electroencephalogram and eye-tracking recordings

Intervention Type OTHER

Participants will perform two tasks: recognize the expression (explicit recognition of the expression) or detect the change in color of the cross (implicit processing of the expression). Each participant will perform two tasks x 6 models x 5 expressions, i.e. 60 stimulations, for a stimulation duration of approximately 30 minutes.

Recognition of the emotional facial expression with a choice among 5 possibilities. Two neutral faces of the same person will be presented side by side. When the participant has looked at the central fixation cross for one second, one of the two faces will produce an expression. The participant will have to indicate as quickly as possible which expression it is, while his or her eye movements are recorded. Each participant will have to recognize 5 expressions x 8 models, i.e. 40 trials for a duration of approximately 5 to 10 minutes

Williams syndrome patients

Electroencephalogram and eye-tracking recordings Behavorial tests

Group Type EXPERIMENTAL

Electroencephalogram and eye-tracking recordings

Intervention Type OTHER

Participants will perform two tasks: recognize the expression (explicit recognition of the expression) or detect the change in color of the cross (implicit processing of the expression). Each participant will perform two tasks x 6 models x 5 expressions, i.e. 60 stimulations, for a stimulation duration of approximately 30 minutes.

Recognition of the emotional facial expression with a choice among 5 possibilities. Two neutral faces of the same person will be presented side by side. When the participant has looked at the central fixation cross for one second, one of the two faces will produce an expression. The participant will have to indicate as quickly as possible which expression it is, while his or her eye movements are recorded. Each participant will have to recognize 5 expressions x 8 models, i.e. 40 trials for a duration of approximately 5 to 10 minutes

Präder Willi syndrome patients

Electroencephalogram and eye-tracking recordings Behavorial tests

Group Type EXPERIMENTAL

Electroencephalogram and eye-tracking recordings

Intervention Type OTHER

Participants will perform two tasks: recognize the expression (explicit recognition of the expression) or detect the change in color of the cross (implicit processing of the expression). Each participant will perform two tasks x 6 models x 5 expressions, i.e. 60 stimulations, for a stimulation duration of approximately 30 minutes.

Recognition of the emotional facial expression with a choice among 5 possibilities. Two neutral faces of the same person will be presented side by side. When the participant has looked at the central fixation cross for one second, one of the two faces will produce an expression. The participant will have to indicate as quickly as possible which expression it is, while his or her eye movements are recorded. Each participant will have to recognize 5 expressions x 8 models, i.e. 40 trials for a duration of approximately 5 to 10 minutes

Control participants

Electroencephalogram and eye-tracking recordings Behavorial tests

Group Type ACTIVE_COMPARATOR

Electroencephalogram and eye-tracking recordings

Intervention Type OTHER

Participants will perform two tasks: recognize the expression (explicit recognition of the expression) or detect the change in color of the cross (implicit processing of the expression). Each participant will perform two tasks x 6 models x 5 expressions, i.e. 60 stimulations, for a stimulation duration of approximately 30 minutes.

Recognition of the emotional facial expression with a choice among 5 possibilities. Two neutral faces of the same person will be presented side by side. When the participant has looked at the central fixation cross for one second, one of the two faces will produce an expression. The participant will have to indicate as quickly as possible which expression it is, while his or her eye movements are recorded. Each participant will have to recognize 5 expressions x 8 models, i.e. 40 trials for a duration of approximately 5 to 10 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electroencephalogram and eye-tracking recordings

Participants will perform two tasks: recognize the expression (explicit recognition of the expression) or detect the change in color of the cross (implicit processing of the expression). Each participant will perform two tasks x 6 models x 5 expressions, i.e. 60 stimulations, for a stimulation duration of approximately 30 minutes.

Recognition of the emotional facial expression with a choice among 5 possibilities. Two neutral faces of the same person will be presented side by side. When the participant has looked at the central fixation cross for one second, one of the two faces will produce an expression. The participant will have to indicate as quickly as possible which expression it is, while his or her eye movements are recorded. Each participant will have to recognize 5 expressions x 8 models, i.e. 40 trials for a duration of approximately 5 to 10 minutes

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Behavorial tests

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals with a genetic condition with psychiatric expression (22q11.2 microdeletion syndrome, Williams syndrome, Präder-Willi syndrome)
* Individuals with schizophrenia according to DSM-5 criteria
* Individuals with Autism Spectrum Disorder (ASD) according to DSM-5 criteria
* Individuals between the ages of 10 and 50
* French native language
* Psychotropic treatment unchanged during the month preceding inclusion
* Stable symptomatology
* Individuals having given their informed consent to participate in the study (consent of legal tutors for minors or under tutorship

Exclusion Criteria

* Recent addiction, excluding tobacco addiction (according to DSM-5 criteria)
* Neurological disorders of vascular, infectious or neurodegenerative origin for patients with schizophrenia or ASD
* Uncorrected visual acuity disorder
* Use of somatic medications that have a cerebral or psychological impact (e.g. corticosteroids)
* Pregnant women
Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

FRANCK NICOLAS, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier le Vinatier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A01367-34

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.