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

Autism Spectrum Disorder Clinical Trial

— ECLAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334588
• Other study ID #: APHP240105
• Secondary ID: 2023-A02668-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2031

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nathalie BODDAERT, MD, PhD
• Phone: +33 1.71.39.65.30
• Email: nathalie.boddaert[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: April 2031
• Est. primary completion date: April 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rest cerebral blood flow (CBF)	Whole brain rest CBF measured with Arterial spin labelling MRI	at inclusion
Secondary	Measurements of white matter microstructure - fractional anisotropy	Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by fractional anisotropy (indicates the orientation of diffusion)	at inclusion
Secondary	Measurements of white matter microstructure - mean diffusivity	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	at inclusion
Secondary	Measurements of white matter microstructure - radial diffusivity	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)	at inclusion
Secondary	Measurements of white matter microstructure - axial diffusivity	Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by axial diffusivity (the magnitude of diffusion parallel to fiber tracts)	at inclusion
Secondary	Measurements of resting state functional connectivity	MRI-resting state measurements of correlation coefficients between different regions within different brain networks, in particular the social brain network.	at inclusion
Secondary	Correlation between social perception and multimodal brain imaging	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.	at inclusion
Secondary	Correlation between clinical severity and multimodal brain imaging	Measures of correlation between autism severity scores measured by the ADI-R and various multimodal brain imaging parameters obtained in MRI	at inclusion
Secondary	Imaging abnormalities associated with known genetic mutations	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.	at inclusion
Secondary	Social perception abnormalities associated with known genetic mutations	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.	at inclusion
Secondary	Anatomic changes over time - study of developmental trajectory	Measures of change over time (between inclusion and 2 years) in brain anatomy and function in a subgroup of ASD patients and healthy volunteers.	2 years
Secondary	Social perception changes over time - study of developmental trajectory	Measures of change over time (between inclusion and 2 years) in social perception parameters in a subgroup of ASD patients and healthy volunteers.	2 years
Secondary	Brain imaging in young children associated with ASD	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)	at inclusion
Secondary	Early data on social perception	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	at inclusion