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Recruiting NCT05635812

Brain and Eye Markers of Facial Expression Recognition and Disorders Associated with Autistic Symptoms

Observational Brain Markers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neuropsychological assessment, EEG experimentation, Oculometry experimentation.
Who it may be relevant to
Registry conditions: Brain Markers. Basic parameters: 7 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Neuropsychological assessment
    neuropsychological assessment and clinical scales duration: 3 hours
  • Other EEG experimentation
    duration: 1 hour
  • Other Oculometry experimentation
    duration: 30 minutes

Primary outcome measures

  • Electrical brain activity in response to visual stimulation measured by electroencephalography [Time frame: at baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Chu Dijon Bourogne — Dijon

Identifiers

NCT: NCT05635812 · PINOIT 2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗