Brain and Eye Markers of Facial Expression Recognition and Disorders Associated With Autistic Symptoms (MARQUEURS)

August 28, 2023 updated by: Centre Hospitalier Universitaire Dijon

In everyday life, it is necessary to adjust one's behavior and reactions in order to interact and communicate with others in an appropriate manner. This adaptation is done by taking into account the emotions of the people with whom we interact. This reading of emotions is done by using visible clues on the face, in particular by observing the eye area of the interlocutor.

The aim of the study is to investigate how processes such as attention or memory influence emotion recognition, as well as (i) their alteration in the disease, and (ii) their link with the emergence of autistic and/or psychotic symptoms. We also want to study the implementation of compensatory strategies (used to compensate for difficulties in recognizing or perceiving emotions) and the link between the correct use of these strategies and the emergence of autistic and/or psychotic symptoms.

The present project plans to include a total of 120 participants: 30 participants with ASD, 30 patients with a particular genetic deletion 22q11.2 and 60 control participants.

After the inclusion visit, participation in the study will be divided into two half-days in order to perform a neuropsychological assessment, an EEG study and an oculometry study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

ASD, 22q11.2 and neurotypical participants

Description

Inclusion Criteria:

  • Person, and if necessary his or her legal representative, who has given his or her non-objection
  • Person whose mother tongue is French.
  • Person aged between 7 and 50 years old.
  • Person diagnosed with ASD according to DSM-5 criteria, person with a genetic syndrome diagnosed by FISH or CGH array (22q11 deletion), person with typical development matched in age and gender.
  • Psychotropic treatment unchanged for one month and stable symptomatology.

Exclusion Criteria:

  • Recent addiction according to DSM-5 criteria, excluding tobacco.
  • Pregnant women.
  • Uncorrected visual acuity disorder.
  • Use of somatic or psychic medication that may alter brain/psychic functioning (e.g. corticosteroids).
  • Neurological disorder of vascular/infectious or neurodegenerative origin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants Autism Spectrum Disorders (ASD)
ASD according to DSM-5 criteria
Other: Neuropsychological assessment
neuropsychological assessment and clinical scales duration: 3 hours
Other: EEG experimentation
duration: 1 hour
Other: Oculometry experimentation
duration: 30 minutes
Participants 22q11.2
Participants with a genetic syndrome diagnosed by FISH or CGH-array
Other: Neuropsychological assessment
neuropsychological assessment and clinical scales duration: 3 hours
Other: EEG experimentation
duration: 1 hour
Other: Oculometry experimentation
duration: 30 minutes
Neurotypical participants
Neurotypical development
Other: Neuropsychological assessment
neuropsychological assessment and clinical scales duration: 3 hours
Other: EEG experimentation
duration: 1 hour
Other: Oculometry experimentation
duration: 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Electrical brain activity in response to visual stimulation measured by electroencephalography
Time Frame: at baseline
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINOIT 2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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