Understanding the Mechanisms of Autism : an MRI and Social Cognition Study
- Conditions
- Autism Spectrum Disorder
- Interventions
- Diagnostic Test: MRIDevice: Eye-trackingOther: Clinical ScalesGenetic: 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
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
- Contraindication to MRI (pacemaker, intracorporeal metallic body, claustrophobia).
- Impossibility for healthy volunteers to remain still during MRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy volunteers over 3 years of age MRI Healthy Control Children will be recruited specifically for the research Suspected or confirmed Autism Spectrum Disorders (ASD) MRI Patient 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 Scales Patient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care Healthy volunteers over 3 years of age Eye-tracking Healthy Control Children will be recruited specifically for the research Healthy volunteers over 3 years of age Clinical Scales Healthy Control Children will be recruited specifically for the research Suspected or confirmed Autism Spectrum Disorders (ASD) Eye-tracking Patient 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 anomalies Patient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care
- Primary Outcome Measures
Name Time Method Rest cerebral blood flow (CBF) at inclusion Whole brain rest CBF measured with Arterial spin labelling MRI
- Secondary Outcome Measures
Name Time Method Measurements of white matter microstructure - mean diffusivity at 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 anisotropy at 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 imaging at 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 mutations at 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 trajectory 2 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 trajectory 2 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 perception at 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 diffusivity at 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 imaging at 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 diffusivity at 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 connectivity at 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 mutations at 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 ASD at 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