Study Stopped
Investigator départure
Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits
FERmarkers
1 other identifier
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2022
CompletedStudy Start
First participant enrolled
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2025
CompletedAugust 3, 2025
July 1, 2025
3.1 years
March 21, 2022
July 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Fast Periodic Visual Stimulation Task (FPVS-EEG)
Fast periodic visual stimulation (FPVS) allows the recording of objective brain responses of human face categorization (i.e., generalizable face-selective responses) with high signal-to-noise ratio.The electrical activity of the brain will be collected using an electroencephalography system (EEG; systems used: ANT and BioSemi) to study the cerebral frequency response to the regular occurrence of facial expressions.
48 months
Secondary Outcomes (1)
Eye-tracking task
48 months
Study Arms (6)
Schizophrenic patients
EXPERIMENTALElectroencephalogram and eye-tracking recordings Behavorial tests
Autism Spectrum Disorder (ASD) patients
EXPERIMENTALElectroencephalogram and eye-tracking recordings
22q11.2 DS patients
EXPERIMENTALElectroencephalogram and eye-tracking recordings Behavorial tests
Williams syndrome patients
EXPERIMENTALElectroencephalogram and eye-tracking recordings Behavorial tests
Präder Willi syndrome patients
EXPERIMENTALElectroencephalogram and eye-tracking recordings Behavorial tests
Control participants
ACTIVE COMPARATORElectroencephalogram and eye-tracking recordings Behavorial tests
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
- Stable symptomatology
- Individuals having given their informed consent to participate in the study (consent of legal tutors for minors or under tutorship
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
centre de réhabilitation - Hôpital le Vinatier
Lyon, Rhône, 69006, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
FRANCK NICOLAS, PhD
Centre Hospitalier le Vinatier
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2022
First Posted
August 15, 2022
Study Start
March 30, 2022
Primary Completion
April 25, 2025
Study Completion
April 25, 2025
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share