Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits (FERmarkers)
Primary Purpose
Autism, Psychotic Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroencephalogram and eye-tracking recordings
Sponsored by
About this trial
This is an interventional basic science trial for Autism
Eligibility Criteria
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
Sites / Locations
- centre de réhabilitation - Hôpital le VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Schizophrenic patients
Autism Spectrum Disorder (ASD) patients
22q11.2 DS patients
Williams syndrome patients
Präder Willi syndrome patients
Control participants
Arm Description
Electroencephalogram and eye-tracking recordings Behavorial tests
Electroencephalogram and eye-tracking recordings
Electroencephalogram and eye-tracking recordings Behavorial tests
Electroencephalogram and eye-tracking recordings Behavorial tests
Electroencephalogram and eye-tracking recordings Behavorial tests
Electroencephalogram and eye-tracking recordings Behavorial tests
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Eye-tracking task
Ocular exploration in the recognition of emotional facial expressions Use of the Eye-tracker (Tobii brand, 250 Hz frequency) to record the participants' eye activity. The task will consist of presenting the neutral face of a person on either side of a fixation cross. The participant will have to stare at the fixation cross for one second to trigger the replacement of one of the two neutral faces by the face of the same person expressing an emotion and will have to identify, as quickly as possible, which of the 5 emotions (anger, disgust, fear, happiness or sadness) is expressed by the face. After the calibration of the participant's gaze, the latter will carry out a training session of 10 trials [2 models (1 woman/1 man) x 5 expressions per model], then an experimental session of 40 trials (6 models (3 women/3 men) x 5 expressions) organized in 2 blocks of 20 trials. The presentation of the trials will be done in a random order.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05501405
Brief Title
Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits
Acronym
FERmarkers
Official Title
Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits Associated With Autistic and Psychotic Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
March 25, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Psychotic Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Brain and eyetracking markers of deficits in recognition of emotional facial expression and associated autistic and/or psychotic disorders
Masking
Participant
Allocation
Non-Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Schizophrenic patients
Arm Type
Experimental
Arm Description
Electroencephalogram and eye-tracking recordings Behavorial tests
Arm Title
Autism Spectrum Disorder (ASD) patients
Arm Type
Experimental
Arm Description
Electroencephalogram and eye-tracking recordings
Arm Title
22q11.2 DS patients
Arm Type
Experimental
Arm Description
Electroencephalogram and eye-tracking recordings Behavorial tests
Arm Title
Williams syndrome patients
Arm Type
Experimental
Arm Description
Electroencephalogram and eye-tracking recordings Behavorial tests
Arm Title
Präder Willi syndrome patients
Arm Type
Experimental
Arm Description
Electroencephalogram and eye-tracking recordings Behavorial tests
Arm Title
Control participants
Arm Type
Active Comparator
Arm Description
Electroencephalogram and eye-tracking recordings Behavorial tests
Intervention Type
Other
Intervention Name(s)
Electroencephalogram and eye-tracking recordings
Other Intervention Name(s)
Behavorial tests
Intervention Description
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
Primary Outcome Measure Information:
Title
Fast Periodic Visual Stimulation Task (FPVS-EEG)
Description
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.
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Eye-tracking task
Description
Ocular exploration in the recognition of emotional facial expressions Use of the Eye-tracker (Tobii brand, 250 Hz frequency) to record the participants' eye activity. The task will consist of presenting the neutral face of a person on either side of a fixation cross. The participant will have to stare at the fixation cross for one second to trigger the replacement of one of the two neutral faces by the face of the same person expressing an emotion and will have to identify, as quickly as possible, which of the 5 emotions (anger, disgust, fear, happiness or sadness) is expressed by the face. After the calibration of the participant's gaze, the latter will carry out a training session of 10 trials [2 models (1 woman/1 man) x 5 expressions per model], then an experimental session of 40 trials (6 models (3 women/3 men) x 5 expressions) organized in 2 blocks of 20 trials. The presentation of the trials will be done in a random order.
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FRANCK NICOLAS, PhD
Phone
0033426738539
Email
nicolas.franck@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
VIAL VERONIQUE
Phone
0033437915522
Email
veronique.vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCK NICOLAS, PhD
Organizational Affiliation
Centre Hospitalier le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
centre de réhabilitation - Hôpital le Vinatier
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Nicolas, PUPH
Phone
+33 (0)437915031
Email
nicolas.franck@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
BAUDOUIN JEAN YVES
Phone
+33 (0)437915031
Email
j.baudouin@univ-lyon2.fr
First Name & Middle Initial & Last Name & Degree
Franck Nicolas
12. IPD Sharing Statement
Plan to Share IPD
No
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Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits
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