Clinical trial NCT06334588: Understanding the Mechanisms of Autism : an MRI and Social Cognition Study
Official title: Understanding the Mechanisms of Autism : an MRI and Social Cognition Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism spectrum disorders
Multimodal brain imaging
Eye-tracking
Social perception
Genetics
Developmental trajectory
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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 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

Primary outcomes:
measure: Rest cerebral blood flow (CBF)
timeFrame: at inclusion
Secondary outcomes:
measure: Measurements of white matter microstructure - fractional anisotropy
timeFrame: at inclusion
measure: Measurements of white matter microstructure - mean diffusivity
timeFrame: at inclusion
measure: Measurements of white matter microstructure - radial diffusivity
timeFrame: at inclusion
measure: Measurements of white matter microstructure - axial diffusivity
timeFrame: at inclusion
measure: Measurements of resting state functional connectivity
timeFrame: at inclusion
measure: Correlation between social perception and multimodal brain imaging
timeFrame: at inclusion
measure: Correlation between clinical severity and multimodal brain imaging
timeFrame: at inclusion
measure: Imaging abnormalities associated with known genetic mutations
timeFrame: at inclusion
measure: Social perception abnormalities associated with known genetic mutations
timeFrame: at inclusion
measure: Anatomic changes over time - study of developmental trajectory
timeFrame: 2 years
measure: Social perception changes over time - study of developmental trajectory
timeFrame: 2 years
measure: Brain imaging in young children associated with ASD
timeFrame: at inclusion
measure: Early data on social perception
timeFrame: at inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
Study officials:
affiliation: INSERM INSERM ERL "Trajectoires Développementales en Psychiatrie"
name: Monica ZILBOVICIUS
role: STUDY_DIRECTOR
References: