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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05194254
Other study ID # PI2021_843_0194
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 4, 2022
Est. completion date May 2024

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Jean-Marc Constans, Pr
Phone 03 22 08 75 15
Email constans.jean-marc@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Most studies use static visual percepts that are less representative of joint attention versus an ecological environment. This has the consequence of decreasing the perception of an interaction with a social partner, which is an essential step in achieving joint attention. The originality of this study is to improve the design of visual percepts (in the form of video) in order to mimic an ecological environment as much as possible by using MRI-ET coupling. The second originality of this study is the longitudinal exploration of the neurodevelopment of social cognition in autistic children. Studies by the Redcay and Oberwelland teams observe different activations at different ages. The hypothesis is that the perception of joint attention varies over time in people with ASD. To date, there are no studies to determine the influence of childhood neurodevelopment in autistic people on the perception of joint attention. It would be unprecedented to use the MRI-ET pairing as a tool for assessing social cognition as a function of the development of children with ASD.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date May 2024
Est. primary completion date January 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 20 Years
Eligibility Inclusion Criteria: For the group of people with Autism Spectrum Disorders (experimental group): - Age between 10 to 20 years old - Diagnosis of ASD (CARS) = 30 performed at inclusion - IQ test evaluation (regardless of the result) performed by a trained psychologist - Obtaining informed oral and written consent after appropriate information - Obtaining informed oral and written consent from the legal guardian after information - Be affiliated with social security - No contraindication to magnetic resonance imaging For the TD (Typical Development) group of people (control group): - Age between 10 to 20 years old - Diagnosis of ASD (CARS) <30 performed at inclusion - IQ test evaluation (regardless of the result) performed by a trained psychologist - Obtaining informed oral and written consent after appropriate information - Obtaining informed oral and written consent from the legal guardian after information - Be affiliated with social security - No contraindication to magnetic resonance imaging Exclusion Criteria: For all groups: - Age outside the range 10 to 20 years - Person with a contraindication to MRI (including claustrophobia, pace maker, neurosurgical clips, vascular clips, heart valves, ventriculoperitoneal valves, cochlear implant, neurostimulator, intraocular metal shards, joint prosthesis, etc.) - Person suffering from major obesity (> 140 kg) not allowing him to enter the tunnel of the MRI machine (diameter <70cm) - Pregnant or breastfeeding woman - Person under guardianship or guardianship or deprived of liberty by a judicial or administrative decision For TD people (control group): - Person with psychiatric disorders such as attention disorder with or without hyperactivity, depression, bipolar disorder and schizophrenia. - Person with a neurological history such as epilepsy and / or neurovascular accident.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
MRI-ET
coupled fMRI and Eye Tracking tools

Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary difference of mapping IRM-ET results between both patient groups both patient groups are : the group of people with Autism Spectrum Disorders and Typical Development group of people one day
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