AutismFERmarkersNCT05501405
Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits
A study testing Electroencephalogram and eye-tracking recordings in people with Autism and Psychotic Disorders, run by Hôpital le Vinatier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Psychotic Disorders
- What is being tested?
- Electroencephalogram and eye-tracking recordings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2022to 25 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits Associated With Autistic and Psychotic Symptoms
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.
Read the 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.
- Conditions
- Autism, Psychotic Disorders
- Being tested
- Electroencephalogram and eye-tracking recordings
- Medical subject headings
- Autistic Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram and eye-tracking recordingsOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenic patients | Experimental | Electroencephalogram and eye-tracking recordings Behavorial tests Receives: Other: Electroencephalogram and eye-tracking recordings |
| Autism Spectrum Disorder (ASD) patients | Experimental | Electroencephalogram and eye-tracking recordings Receives: Other: Electroencephalogram and eye-tracking recordings |
| 22q11.2 DS patients | Experimental | Electroencephalogram and eye-tracking recordings Behavorial tests Receives: Other: Electroencephalogram and eye-tracking recordings |
| Williams syndrome patients | Experimental | Electroencephalogram and eye-tracking recordings Behavorial tests Receives: Other: Electroencephalogram and eye-tracking recordings |
| Präder Willi syndrome patients | Experimental | Electroencephalogram and eye-tracking recordings Behavorial tests Receives: Other: Electroencephalogram and eye-tracking recordings |
| Control participants | Active comparator | Electroencephalogram and eye-tracking recordings Behavorial tests Receives: Other: Electroencephalogram and eye-tracking recordings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Secondary outcomes (1)
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start30 Mar 2022
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Why it stopped: Investigator départure No analysis will be carried out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Brain and eyetracking markers of deficits in recognition of emotional facial expression and associated autistic and/or psychotic disorders
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FRANCK NICOLAS, PhD, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501405
- Sponsor's protocol ID
- 2021-A01367-34
- Acronym
- FERmarkers
- Status last verified
- Jun 2026
- First submitted
- 21 Mar 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits Associated With Autistic and Psychotic Symptoms
- ClinicalTrials.gov ID
- NCT05501405
- Acronym / sponsor ID
- FERmarkers / 2021-A01367-34
- Conditions
- Autism, Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator départure No analysis will be carried out
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Brain and eyetracking markers of deficits in recognition of emotional facial expression and associated autistic and/or psychotic disorders
| Arm | Type | Receives |
|---|---|---|
| Schizophrenic patients | Experimental | Other: Electroencephalogram and eye-tracking recordingsElectroencephalogram and eye-tracking recordings Behavorial tests |
| Autism Spectrum Disorder (ASD) patients | Experimental | Other: Electroencephalogram and eye-tracking recordingsElectroencephalogram and eye-tracking recordings |
| 22q11.2 DS patients | Experimental | Other: Electroencephalogram and eye-tracking recordingsElectroencephalogram and eye-tracking recordings Behavorial tests |
| Williams syndrome patients | Experimental | Other: Electroencephalogram and eye-tracking recordingsElectroencephalogram and eye-tracking recordings Behavorial tests |
| Präder Willi syndrome patients | Experimental | Other: Electroencephalogram and eye-tracking recordingsElectroencephalogram and eye-tracking recordings Behavorial tests |
| Control participants | Active comparator | Other: Electroencephalogram and eye-tracking recordingsElectroencephalogram and eye-tracking recordings Behavorial tests |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroencephalogram and eye-tracking recordingsAlso: Behavorial testsParticipants 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 | 22q11.2 DS patients, Autism Spectrum Disorder (ASD) patients, Control participants, Präder Willi syndrome patients, Schizophrenic patients, Williams syndrome patients |
Primary outcome
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.
1 secondary outcome
Eye-tracking task
Time frame: 48 months
Results and safety
The study was stopped early (reason given: Investigator départure No analysis will be carried out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FRANCK NICOLAS, PhD principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalogram and eye-tracking recordings in people with Autism and Psychotic Disorders, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator départure No analysis will be carried out). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fast Periodic Visual Stimulation Task (FPVS-EEG) (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.