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NCT Number: NCT06334588

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

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

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Key information

Age range

3 month–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

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 :

  • 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

Treatment and study plan

MRI

Diagnostic Test

Anatomical and functional images will be acquired and review by an experienced neuro-radiologist

Eye-tracking

Device

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

Clinical Scales

Other

CGI, E-CAR and ABC will be used for behavior and clinical evaluation

Research of genetic anomalies

Genetic

For the diagnosis of autism, patients benefit from a a genetic assessment. This is carried out as part of their care

Primary outcomes

  1. Rest cerebral blood flow (CBF)

    Time frame: at inclusion

    Whole brain rest CBF measured with Arterial spin labelling MRI

Secondary outcomes

  1. Measurements of white matter microstructure - fractional anisotropy

    Time frame: at inclusion

    Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by fractional anisotropy (indicates the orientation of diffusion)

  2. Measurements of white matter microstructure - mean diffusivity

    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

  3. Measurements of white matter microstructure - radial diffusivity

    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)

  4. Measurements of white matter microstructure - axial diffusivity

    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)

  5. Measurements of resting state functional connectivity

    Time frame: at inclusion

    MRI-resting state measurements of correlation coefficients between different regions within different brain networks, in particular the social brain network.

  6. Correlation between social perception and multimodal brain imaging

    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.

  7. Correlation between clinical severity and multimodal brain imaging

    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

  8. Imaging abnormalities associated with known genetic mutations

    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.

  9. Social perception abnormalities associated with known genetic mutations

    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.

  10. Anatomic changes over time - study of developmental trajectory

    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.

  11. Social perception changes over time - study of developmental trajectory

    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.

  12. Brain imaging in young children associated with ASD

    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)

  13. Early data on social perception

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie BODDAERT, MD, PhD

CONTACT

[email protected]

+33 1.71.39.65.30

Victor BRUYERE, Master

CONTACT

[email protected]

+ 33 1 34 29 23 24

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: ECLAT

Important dates

Study start
2024
Primary completion
2029
Study completion
2031
First posted
Mar 28, 2024
Registry last updated
Dec 23, 2025

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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