Understanding the Mechanisms of Autism : an MRI and Social Cognition Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI, Eye-tracking, Clinical Scales, Research of genetic anomalies.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 months — 28 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Diagnostic test MRI
Anatomical and functional images will be acquired and review by an experienced neuro-radiologist - Device Eye-tracking
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 - Other Clinical Scales
CGI, E-CAR and ABC will be used for behavior and clinical evaluation - Genetic Research of genetic anomalies
For the diagnosis of autism, patients benefit from a a genetic assessment. This is carried out as part of their care
Primary outcome measures
- Rest cerebral blood flow (CBF) [Time frame: at inclusion]
Secondary outcome measures (12)
- Measurements of white matter microstructure - fractional anisotropy [Time frame: at inclusion]
- Measurements of white matter microstructure - mean diffusivity [Time frame: at inclusion]
- Measurements of white matter microstructure - radial diffusivity [Time frame: at inclusion]
- Measurements of white matter microstructure - axial diffusivity [Time frame: at inclusion]
- Measurements of resting state functional connectivity [Time frame: at inclusion]
- Correlation between social perception and multimodal brain imaging [Time frame: at inclusion]
- Correlation between clinical severity and multimodal brain imaging [Time frame: at inclusion]
- Imaging abnormalities associated with known genetic mutations [Time frame: at inclusion]
- Social perception abnormalities associated with known genetic mutations [Time frame: at inclusion]
- Anatomic changes over time - study of developmental trajectory [Time frame: 2 years]
- Social perception changes over time - study of developmental trajectory [Time frame: 2 years]
- Brain imaging in young children associated with ASD [Time frame: at inclusion]
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Hôpital Necker Enfants Malades — Paris
Identifiers
NCT: NCT06334588 · APHP240105 · 2023-A02668-37