MRI Study of Subjects with ASD, Their Relatives and TD

Last updated: March 11, 2025
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Williams Syndrome

Treatment

Neuroimaging (MRI)

Clinical Study ID

NCT05470088
C16-90
2017-A02356-47
  • Ages > 24
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • for patients:

  • being included in the main study "C16-89 - Study of genetic factors involved inASD and related disorders"

  • having an ASD fulfilling DSM-5 diagnostic criteria (APA, 2012). Diagnosis willbe 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 thesubject is <18 or under legal custody)

  • for relatives

  • being included in the main study "C16-89 - Study of genetic factors involved inASD and related disorders"

  • having at least 24 Months

  • being affiliated with the French health insurance

  • having signed the informed consent (by proposant or by legal tutors if thesubject is <18 or under legal custody)

  • for controls

  • being included in the main study "C16-89 - Study of genetic factors involved inASD and related disorders"

  • having at least 24 Months

  • being affiliated with the French health insurance

  • having signed the informed consent (by proposant or by legal tutors if thesubject is <18 or under legal custody)

Non-inclusion criteria:

  • for all subjects

  • severe mental retardation (IQ<35 or developmental age<18 months)

  • medical condition (either psychiatric or physical) not compatible with aninclusion

  • MRI counter indication

  • Current pregnancy or breastfeeding, assessed by questionnaire

  • Not willing to be informed of a brain abnormality diagnosed with MRI

  • for the relatives

*discovery of non filiation during the genetic analyses

  • for controls

  • Neurological history (except mental retardation)

  • Personal history of (checked with DIGS for Adults, Diagnostic Interview forGenetic Studies, Numberger et coll., 1994, or Kiddie SADS, Kiddie Schedule forDisorders and Schizophrenia for School Age Children, Orvaschel et coll., 1982):schizophrenia, addiction, bipolar disorder, recurrent depression (> 2 episodeslifetime), severe, not stabilized anxiety disorder, history of episodes ofepilepsy, significant inflammatory disease of immunosuppressive medication

Exclusion

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)

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Neuroimaging (MRI)
Phase:
Study Start date:
March 13, 2022
Estimated Completion Date:
September 13, 2039

Connect with a study center

  • NeuroSpin neuroimaging platforme

    Gif-sur-Yvette, 91191
    France

    Site Not Available

  • APHP, Hôpital Robert Debré

    Paris, 75019
    France

    Active - Recruiting

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