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NCT Number: NCT05470088

MRI Study of Subjects with ASD, Their Relatives and TD

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

Recruiting

Interested in participating?

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

24 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NeuroSpin neuroimaging platforme, Gif-sur-Yvette, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • having signed the informed consent (by proposant or by legal tutors if the subject is <18 or under legal custody)
  • for controls
  • 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
  • having signed the informed consent (by proposant or by legal tutors if the subject 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 an inclusion
  • 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 for Genetic Studies, Numberger et coll., 1994, or Kiddie SADS, Kiddie Schedule for Disorders and Schizophrenia for School Age Children, Orvaschel et coll., 1982): schizophrenia, addiction, bipolar disorder, recurrent depression (> 2 episodes lifetime), severe, not stabilized anxiety disorder, history of episodes of epilepsy, significant inflammatory disease of immunosuppressive medication

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)

Treatment and study plan

Neuroimaging (MRI)

Other

Multimodal magnetic resonance imaging

Primary outcomes

  1. 3DT1 MRI derived variables

    Time frame: Day 0

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

  2. Resting state fMRI derived variables

    Time frame: Day 0

    Whole-brain BOLD signal correlations

  3. Task based fMRI derived variables

    Time frame: Day 0

    BOLD activation signals BOLD signal correlations

  4. Diffusion MRI derived variables

    Time frame: Day 0

    Fractional anisotropy and mean diffusivity NODDI derived variables

  5. quantitative T1 and quantitative T2 MRI

    Time frame: Day 0

    Myelin Water Fraction

Study contacts

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

Josselin Houenou, M.D, Ph.D

CONTACT

[email protected]

+33149813051

Richard Delorme, M.D, Ph.D

CONTACT

[email protected]

+33140032002

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • APHP
  • Commissariat A L'energie Atomique
  • Institut Pasteur

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2037
Study completion
2039
First posted
Jul 22, 2022
Registry last updated
Mar 13, 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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