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

NCT06334588 | Recruiting

• 2 other identifiers: APHP2401052023-A02668-37
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Autism Spectrum Disorder

Keywords

Autism spectrum disorders; Multimodal brain imaging; Eye-tracking; Social perception; Genetics; Developmental trajectory

Outcome Measures

Primary Outcomes (1)

• Rest cerebral blood flow (CBF)

  Whole brain rest CBF measured with Arterial spin labelling MRI

  at inclusion

Secondary Outcomes (13)

• Measurements of white matter microstructure - fractional anisotropy

  at inclusion

• Measurements of white matter microstructure - mean diffusivity

  at inclusion

• Measurements of white matter microstructure - radial diffusivity

  at inclusion

• Measurements of white matter microstructure - axial diffusivity

  at inclusion

• Measurements of resting state functional connectivity

  at inclusion

Study Arms (3)

Suspected or confirmed Autism Spectrum Disorders (ASD)

EXPERIMENTAL

Patient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care

Diagnostic Test: MRI; Device: Eye-tracking; Other: Clinical Scales; Genetic: Research of genetic anomalies

Healthy volunteers over 3 years of age

EXPERIMENTAL

Healthy Control Children will be recruited specifically for the research

Diagnostic Test: MRI; Device: Eye-tracking; Other: Clinical Scales

Healthy volunteers under 5 years of age

NO INTERVENTION

Children who have already undergone an MRI for various medical reasons and whose MRI was normal.

Interventions

MRI DIAGNOSTIC_TEST

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

Healthy volunteers over 3 years of age; Suspected or confirmed Autism Spectrum Disorders (ASD)

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

Healthy volunteers over 3 years of age; Suspected or confirmed Autism Spectrum Disorders (ASD)

Clinical Scales OTHER

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

Healthy volunteers over 3 years of age; Suspected or confirmed Autism Spectrum Disorders (ASD)

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

Suspected or confirmed Autism Spectrum Disorders (ASD)

Eligibility Criteria

• Age: 3 Months - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For subjects diagnosed with ASD or suspected of ASD :
• 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

You may not qualify if:

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

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Monica ZILBOVICIUS

  INSERM INSERM ERL "Trajectoires Développementales en Psychiatrie"

  STUDY DIRECTOR

Central Study Contacts

Nathalie BODDAERT, MD, PhD

CONTACT

+33 1.71.39.65.30; nathalie.boddaert@aphp.fr

Victor BRUYERE, Master

CONTACT

+ 33 1 34 29 23 24; victor.bruyere@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 28, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2031
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)