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Clinical Trials/NCT05470088
NCT05470088
Recruiting
N/A

Magnetic Resonance Imaging Neuroanatomical Study of Patients with an Autism Spectrum Disorder, Their Relatives and Typically Developing Subjects.

Institut National de la Santé Et de la Recherche Médicale, France2 sites in 1 country1,000 target enrollmentMarch 13, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
1000
Locations
2
Primary Endpoint
3DT1 MRI derived variables
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This project is structured around a central study called "Study of genetic factors involved in autism and related conditions ("Genes and Autism" study, sponsor: INSERM). This study explores clinical and genetic aspects of ASD (autism spectrum disorders) and is complemented with several ancillary studies (such as this one) which will use the data of the main study and will allow an extensive review of phenotypes associated with ASD.

In this ancillary study, we will go on the acquisition of anatomical, diffusion and functional MRI in subjects with ASD, relatives and controls. Our group has already performed several neuroanatomical studies of ASD. IWe recruited since 2010 more than 600 subjects (proponents, relatives and controls) to better understand the implication of brain abnormalities in ASD.

This study involves specialized teams in neuroiamging based at INSERM, NeuroSpin (CEA), Robert Debré Hospital (APHP) and Pasteur Institute

Our main objective is to identify structural, connectivity and functional peculiarities in subjects with ASD

Secondary objectives include:

  • the identification of familial heritability patterns of ASD
  • correlate data obtained in brain imaging with genetic data
  • assess specificity and statistical reproducibility of the obtained results
Registry
clinicaltrials.gov
Start Date
March 13, 2022
End Date
September 13, 2039
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • for patients:
  • being included in the main study "C16-89 - Study of genetic factors involved in ASD and related disorders"
  • having an ASD fulfilling DSM-5 diagnostic criteria (APA, 2012). Diagnosis will be done by a clinical expert, with the support of structured instruments (ADI-R, ADOS-2)
  • having at least 24 Months
  • being affiliated with the French health insurance
  • having signed the informed consent (by proposant or by legal tutors if the subject is \<18 or under legal custody)
  • for relatives
  • being included in the main study "C16-89 - Study of genetic factors involved in ASD and related disorders"
  • having at least 24 Months
  • being affiliated with the French health insurance

Exclusion Criteria

  • for patients: ASD diagnosis not confirmed by assessments after the inclusion
  • for all subjects: discovery of a counter indication to MRI during the exam (e.g. claustrophobia)

Outcomes

Primary Outcomes

3DT1 MRI derived variables

Time Frame: Day 0

Cortical folding Cortical thickness Cortical surface Cortical, white matter and subcortical volumes

Task based fMRI derived variables

Time Frame: Day 0

BOLD activation signals BOLD signal correlations

Resting state fMRI derived variables

Time Frame: Day 0

Whole-brain BOLD signal correlations

Diffusion MRI derived variables

Time Frame: Day 0

Fractional anisotropy and mean diffusivity NODDI derived variables

quantitative T1 and quantitative T2 MRI

Time Frame: Day 0

Myelin Water Fraction

Study Sites (2)

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