Understanding the Mechanisms of Autism : an MRI and Social Cognition Study (ECLAT)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Genetic: Research of genetic anomalies; Other: Clinical Scales; Device: Eye-tracking; Diagnostic Test: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06334588

APHP240105

2023-A02668-37 (Registry Identifier)

Details and patient eligibility

About

The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking

Full description

Autism Spectrum Disorders (ASD) are neurodevelopmental disorders whose first manifestations appear early in childhood. Even if ASDs present a wide heterogeneity in clinical manifestations, abnormalities in social behavior, characterized in particular by a lack of preference for social information, remain the core of difficulties characteristic of autism.

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

Enrollment: 160 estimated patients

Sex: All

Ages: 3 months to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For subjects diagnosed with ASD or suspected of ASD :

• 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 18 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

• Contraindication to MRI (pacemaker, intracorporeal metallic body, claustrophobia).
• Impossibility for healthy volunteers to remain still during MRI

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

Suspected or confirmed Autism Spectrum Disorders (ASD)

Experimental group

Description:

Patient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care

Treatment:

Other: Clinical Scales

Genetic: Research of genetic anomalies

Device: Eye-tracking

Diagnostic Test: MRI

Healthy volunteers over 3 years of age

Experimental group

Description:

Healthy Control Children will be recruited specifically for the research

Treatment:

Other: Clinical Scales

Device: Eye-tracking

Diagnostic Test: MRI

Healthy volunteers under 5 years of age

No Intervention group

Description:

Children who have already undergone an MRI for various medical reasons and whose MRI was normal.