MedPath

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

Not Applicable
Not yet recruiting
Conditions
Autism Spectrum Disorder
Interventions
Diagnostic Test: MRI
Device: Eye-tracking
Other: Clinical Scales
Genetic: Research of genetic anomalies
Registration Number
NCT06334588
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Brief Summary

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

Detailed 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

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
160
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
Read More
Exclusion Criteria
  • Contraindication to MRI (pacemaker, intracorporeal metallic body, claustrophobia).
  • Impossibility for healthy volunteers to remain still during MRI
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Healthy volunteers over 3 years of ageMRIHealthy Control Children will be recruited specifically for the research
Suspected or confirmed Autism Spectrum Disorders (ASD)MRIPatient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care
Suspected or confirmed Autism Spectrum Disorders (ASD)Clinical ScalesPatient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care
Healthy volunteers over 3 years of ageEye-trackingHealthy Control Children will be recruited specifically for the research
Healthy volunteers over 3 years of ageClinical ScalesHealthy Control Children will be recruited specifically for the research
Suspected or confirmed Autism Spectrum Disorders (ASD)Eye-trackingPatient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care
Suspected or confirmed Autism Spectrum Disorders (ASD)Research of genetic anomaliesPatient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care
Primary Outcome Measures
NameTimeMethod
Rest cerebral blood flow (CBF)at inclusion

Whole brain rest CBF measured with Arterial spin labelling MRI

Secondary Outcome Measures
NameTimeMethod
Measurements of white matter microstructure - mean diffusivityat inclusion

Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by mean diffusivity (the mean amount of diffusion in each of the principal directions calculated in the tensor

Measurements of white matter microstructure - fractional anisotropyat inclusion

Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by fractional anisotropy (indicates the orientation of diffusion)

Correlation between social perception and multimodal brain imagingat inclusion

Correlation measurements between social perception parameters measured by eye-tracking (number of fixations in social and non-social regions) and various multimodal brain imaging parameters obtained with MRI.

Imaging abnormalities associated with known genetic mutationsat inclusion

Multimodal brain imaging in patients with a known genetic abnormality compared with the same measures obtained in patients without known genetic abnormalities or in healthy controls.

Anatomic changes over time - study of developmental trajectory2 years

Measures of change over time (between inclusion and 2 years) in brain anatomy and function in a subgroup of ASD patients and healthy volunteers.

Social perception changes over time - study of developmental trajectory2 years

Measures of change over time (between inclusion and 2 years) in social perception parameters in a subgroup of ASD patients and healthy volunteers.

Early data on social perceptionat inclusion

Social perception measures (number of fixations in social and non-social regions) in very young patients with ASD (3 months to 5 years) compared with a subgroup of control children aged under 5 years

Measurements of white matter microstructure - axial diffusivityat inclusion

Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by axial diffusivity (the magnitude of diffusion parallel to fiber tracts)

Correlation between clinical severity and multimodal brain imagingat inclusion

Measures of correlation between autism severity scores measured by the ADI-R and various multimodal brain imaging parameters obtained in MRI

Measurements of white matter microstructure - radial diffusivityat inclusion

Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by radial diffusivity (the apparent water diffusion coefficient in the direction perpendicular to the axonal fibers)

Measurements of resting state functional connectivityat inclusion

MRI-resting state measurements of correlation coefficients between different regions within different brain networks, in particular the social brain network.

Social perception abnormalities associated with known genetic mutationsat inclusion

Social perception measures (number of fixations in social and non-social regions) in patients with a known genetic abnormality compared with the same measures obtained in patients without known genetic abnormalities or in healthy controls.

Brain imaging in young children associated with ASDat inclusion

Multimodal brain imaging measures in young patients (\<5 years) with a ASD compared with the same measures obtained in young children (\<5 years) without ASD (control children)

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades

🇫🇷

Paris, France

© Copyright 2025. All Rights Reserved by MedPath