- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05194254
MRI-Eye Tracking Pairing, a Tool for Assessing Social Cognition in Children With ASD (IRM-ET)
May 22, 2025 updated by: Centre Hospitalier Universitaire, Amiens
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
68
Phase
- Not Applicable
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
- Name: Jean-Marc Constans, Pr
- Phone Number: 03 22 08 75 15
- Email: constans.jean-marc@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- Recruiting
- CHU Amiens Picardie
-
Contact:
- Jean-Marc CONSTANS, PhD
- Phone Number: +33322087511
- Email: constans.jean-marc@chu-amiens.fr
-
Sub-Investigator:
- Olivier Balédent, PHD
-
Sub-Investigator:
- Luc VANDROMME, Pr
-
-
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
10 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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 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
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ASD
people with Autism Spectrum Disorders
|
coupled fMRI and Eye Tracking tools
|
|
Active Comparator: TD
Typical Development) group of people
|
coupled fMRI and Eye Tracking tools
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
difference of mapping IRM-ET results between both patient groups
Time Frame: one day
|
both patient groups are : the group of people with Autism Spectrum Disorders and Typical Development group of people
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 4, 2022
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
January 4, 2022
First Submitted That Met QC Criteria
January 4, 2022
First Posted (Actual)
January 18, 2022
Study Record Updates
Last Update Posted (Actual)
May 28, 2025
Last Update Submitted That Met QC Criteria
May 22, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- PI2021_843_0194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.