Understanding the Mechanisms of Autism : an MRI and Social Cognition Study
NCT ID: NCT06334588
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2024-04-17
2031-04-30
Brief Summary
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Detailed Description
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Brain imaging investigations have revealed anatomo-functional abnormalities in autism, particularly in social brain regions. In parallel, eye-tracking studies have provided objective measures of social perception abnormalities in autism. These results illustrate the relevance of these research strategies in the context of ASD. Acquiring objective data on social behavior and linking them with brain imaging data opens up new avenues for research into the evolution of social skills during child development, and the brain changes underlying this process.
In this context, the main hypothesis of this study is that the investigation of the neural bases of autism spectrum disorders, using an approach combining multimodal brain imaging and the investigation of social behavior using eye-tracking, would make it possible not only to better describe abnormalities, but also to identify individual patterns at brain and behavioral level. This could help to better characterize ASDs with and without genetic abnormalities, an area which to date has received very little investigation. In addition, the objective measurements obtained with this approach would also enable the proposal of biomarkers, which would contribute not only to better monitoring of the disorder's evolution, but also to the evaluation of the effectiveness of new therapeutic interventions
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Suspected or confirmed Autism Spectrum Disorders (ASD)
Patient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care
MRI
Anatomical and functional images will be acquired and review by an experienced neuro-radiologist
Eye-tracking
Eye movements and follow a person's gaze will be recorded during visualization of stimuli presented in the screen by analyzing images of the eye captured by an infrared camera
Clinical Scales
CGI, E-CAR and ABC will be used for behavior and clinical evaluation
Research of genetic anomalies
For the diagnosis of autism, patients benefit from a a genetic assessment. This is carried out as part of their care
Healthy volunteers over 3 years of age
Healthy Control Children will be recruited specifically for the research
MRI
Anatomical and functional images will be acquired and review by an experienced neuro-radiologist
Eye-tracking
Eye movements and follow a person's gaze will be recorded during visualization of stimuli presented in the screen by analyzing images of the eye captured by an infrared camera
Clinical Scales
CGI, E-CAR and ABC will be used for behavior and clinical evaluation
Healthy volunteers under 5 years of age
Children who have already undergone an MRI for various medical reasons and whose MRI was normal.
No interventions assigned to this group
Interventions
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MRI
Anatomical and functional images will be acquired and review by an experienced neuro-radiologist
Eye-tracking
Eye movements and follow a person's gaze will be recorded during visualization of stimuli presented in the screen by analyzing images of the eye captured by an infrared camera
Clinical Scales
CGI, E-CAR and ABC will be used for behavior and clinical evaluation
Research of genetic anomalies
For the diagnosis of autism, patients benefit from a a genetic assessment. This is carried out as part of their care
Eligibility Criteria
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Inclusion Criteria
* 3 months ≤ age \< 25 years ;
* an MRI required as part of the clinical procedures
* written consent obtained from parents or legal guardians.
* Affiliated to social security
For Healthy control subjects over 3 years of age:
* between 3 and 28 years of age
* no known neurological or psychiatric pathology
* written consent obtained from parents or legal guardian.
* Affiliated to social security
For Healthy control subjects under 5 years of age:
* age between 3 months and 5 years
* who have had an MRI scan in the pediatric radiology department at Necker Hospital, which was found to be normal.
* with no known neurological or psychiatric pathology
* no opposition from legal representative
Exclusion Criteria
* Impossibility for healthy volunteers to remain still during MRI
3 Months
28 Years
ALL
Yes
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Monica ZILBOVICIUS
Role: STUDY_DIRECTOR
INSERM INSERM ERL "Trajectoires Développementales en Psychiatrie"
Locations
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Hôpital Necker Enfants Malades
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Nathalie BODDAERT, MD, PhD
Role: primary
Other Identifiers
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APHP240105
Identifier Type: -
Identifier Source: org_study_id
2023-A02668-37
Identifier Type: REGISTRY
Identifier Source: secondary_id