MRI Study of Subjects with ASD, Their Relatives and TD

NCT ID: NCT05470088

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-13

Study Completion Date

2039-09-13

Brief Summary

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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

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects with Autism Spectrum Disorders

Neuroimaging (MRI)

Intervention Type OTHER

Multimodal magnetic resonance imaging

Relatives of subjects with Autism Spectrum Disorders

Neuroimaging (MRI)

Intervention Type OTHER

Multimodal magnetic resonance imaging

Typically developing subjects

Neuroimaging (MRI)

Intervention Type OTHER

Multimodal magnetic resonance imaging

Interventions

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Neuroimaging (MRI)

Multimodal magnetic resonance imaging

Intervention Type OTHER

Eligibility Criteria

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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)


* 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)
Minimum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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APHP

OTHER

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role collaborator

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Delorme, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

APHP, France

Josselin Houenou, M.D, Ph.D

Role: STUDY_CHAIR

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

Locations

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NeuroSpin neuroimaging platforme

Gif-sur-Yvette, , France

Site Status NOT_YET_RECRUITING

APHP, Hôpital Robert Debré

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Richard Delorme, M.D, Ph.D

Role: CONTACT

+33140032002

Josselin Houenou, M.D, Ph.D

Role: CONTACT

+33149813051

Facility Contacts

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Josselin Houenou, MD, PhD

Role: primary

Richard Delorme, MD, PhD

Role: primary

Other Identifiers

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2017-A02356-47

Identifier Type: REGISTRY

Identifier Source: secondary_id

C16-90

Identifier Type: -

Identifier Source: org_study_id

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