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Clinical Trials/NCT06334588
NCT06334588
Recruiting
N/A

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country160 target enrollmentApril 17, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
160
Locations
1
Primary Endpoint
Rest cerebral blood flow (CBF)
Status
Recruiting
Last Updated
4 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 17, 2024
End Date
April 1, 2031
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 28 years of age
  • no known neurological or psychiatric pathology
  • written consent obtained from parents or legal guardian.
  • Affiliated to social security

Exclusion Criteria

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

Outcomes

Primary Outcomes

Rest cerebral blood flow (CBF)

Time Frame: at inclusion

Whole brain rest CBF measured with Arterial spin labelling MRI

Secondary Outcomes

  • Measurements of white matter microstructure - mean diffusivity(at inclusion)
  • Measurements of white matter microstructure - fractional anisotropy(at inclusion)
  • Correlation between social perception and multimodal brain imaging(at inclusion)
  • Imaging abnormalities associated with known genetic mutations(at inclusion)
  • Anatomic changes over time - study of developmental trajectory(2 years)
  • Social perception changes over time - study of developmental trajectory(2 years)
  • Early data on social perception(at inclusion)
  • Measurements of white matter microstructure - axial diffusivity(at inclusion)
  • Correlation between clinical severity and multimodal brain imaging(at inclusion)
  • Measurements of white matter microstructure - radial diffusivity(at inclusion)
  • Measurements of resting state functional connectivity(at inclusion)
  • Social perception abnormalities associated with known genetic mutations(at inclusion)
  • Brain imaging in young children associated with ASD(at inclusion)

Study Sites (1)

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