Hôpital Necker Enfants Malades
Paris, 75015, France
Location status: Recruiting
NCT Number: NCT06334588
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
Interested in participating?
Request Info3 month–28 year
All sexes
Interventional
Not applicable
Paris, 75015, France
Location status: Recruiting
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For subjects diagnosed with ASD or suspected of ASD :
For Healthy control subjects over 3 years of age:
For Healthy control subjects under 5 years of age:
Exclusion criteria
Anatomical and functional images will be acquired and review by an experienced neuro-radiologist
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
CGI, E-CAR and ABC will be used for behavior and clinical evaluation
For the diagnosis of autism, patients benefit from a a genetic assessment. This is carried out as part of their care
Time frame: at inclusion
Whole brain rest CBF measured with Arterial spin labelling MRI
Time frame: at inclusion
Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by fractional anisotropy (indicates the orientation of diffusion)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: at inclusion
MRI-resting state measurements of correlation coefficients between different regions within different brain networks, in particular the social brain network.
Time frame: 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.
Time frame: at inclusion
Measures of correlation between autism severity scores measured by the ADI-R and various multimodal brain imaging parameters obtained in MRI
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Contact information is provided by the study sponsor or research team.
Nathalie BODDAERT, MD, PhD
CONTACT
Victor BRUYERE, Master
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: ECLAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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