- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05501405
Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits (FERmarkers)
Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits Associated With Autistic and Psychotic Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: FRANCK NICOLAS, PhD
- Phone Number: 0033426738539
- Email: nicolas.franck@ch-le-vinatier.fr
Study Contact Backup
- Name: VIAL VERONIQUE
- Phone Number: 0033437915522
- Email: veronique.vial@ch-le-vinatier.fr
Study Locations
-
-
Rhône
-
Lyon, Rhône, France, 69006
- Recruiting
- centre de réhabilitation - Hôpital le Vinatier
-
Contact:
- Franck Nicolas, PUPH
- Phone Number: +33 (0)437915031
- Email: nicolas.franck@ch-le-vinatier.fr
-
Contact:
- BAUDOUIN JEAN YVES
- Phone Number: +33 (0)437915031
- Email: j.baudouin@univ-lyon2.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Schizophrenic patients
Electroencephalogram and eye-tracking recordings Behavorial tests
|
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
Other Names:
|
Experimental: Autism Spectrum Disorder (ASD) patients
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
Other Names:
|
Experimental: 22q11.2 DS patients
Electroencephalogram and eye-tracking recordings Behavorial tests
|
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
Other Names:
|
Experimental: Williams syndrome patients
Electroencephalogram and eye-tracking recordings Behavorial tests
|
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
Other Names:
|
Experimental: Präder Willi syndrome patients
Electroencephalogram and eye-tracking recordings Behavorial tests
|
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
Other Names:
|
Active Comparator: Control participants
Electroencephalogram and eye-tracking recordings Behavorial tests
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fast Periodic Visual Stimulation Task (FPVS-EEG)
Time Frame: 48 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eye-tracking task
Time Frame: 48 months
|
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.
|
48 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: FRANCK NICOLAS, PhD, Centre Hospitalier Le Vinatier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A01367-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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