NCT05501405

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

3.1 years

First QC Date

March 21, 2022

Last Update Submit

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

EXPERIMENTAL

Electroencephalogram and eye-tracking recordings Behavorial tests

Other: Electroencephalogram and eye-tracking recordings

Autism Spectrum Disorder (ASD) patients

EXPERIMENTAL

Electroencephalogram and eye-tracking recordings

Other: Electroencephalogram and eye-tracking recordings

22q11.2 DS patients

EXPERIMENTAL

Electroencephalogram and eye-tracking recordings Behavorial tests

Other: Electroencephalogram and eye-tracking recordings

Williams syndrome patients

EXPERIMENTAL

Electroencephalogram and eye-tracking recordings Behavorial tests

Other: Electroencephalogram and eye-tracking recordings

Präder Willi syndrome patients

EXPERIMENTAL

Electroencephalogram and eye-tracking recordings Behavorial tests

Other: Electroencephalogram and eye-tracking recordings

Control participants

ACTIVE COMPARATOR

Electroencephalogram and eye-tracking recordings Behavorial tests

Other: Electroencephalogram and eye-tracking recordings

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

Also known as: Behavorial tests
22q11.2 DS patientsAutism Spectrum Disorder (ASD) patientsControl participantsPräder Willi syndrome patientsSchizophrenic patientsWilliams syndrome patients

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Conditions

Autistic DisorderPsychotic Disorders

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • FRANCK NICOLAS, PhD

    Centre Hospitalier le Vinatier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Brain and eyetracking markers of deficits in recognition of emotional facial expression and associated autistic and/or psychotic disorders
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

Locations