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MRI Study of Subjects With ASD, Their Relatives and TD

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ClinicalTrials.gov Identifier: NCT05470088
Recruitment Status : Recruiting
First Posted : July 22, 2022
Last Update Posted : August 4, 2022
Sponsor:
Collaborators:
APHP
Institut Pasteur
Commissariat A L'energie Atomique
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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

Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: Neuroimaging (MRI)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Magnetic Resonance Imaging Neuroanatomical Study of Patients With an Autism Spectrum Disorder, Their Relatives and Typically Developing Subjects.
Actual Study Start Date : March 13, 2022
Estimated Primary Completion Date : September 13, 2023
Estimated Study Completion Date : September 13, 2039

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Subjects with Autism Spectrum Disorders Other: Neuroimaging (MRI)
Multimodal magnetic resonance imaging

Relatives of subjects with Autism Spectrum Disorders Other: Neuroimaging (MRI)
Multimodal magnetic resonance imaging

Typically developing subjects Other: Neuroimaging (MRI)
Multimodal magnetic resonance imaging




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Three groups of subjects above 24 months (no upper limit of age):

  • subjects with ASD
  • relatives of subjects with ASD
  • typically developing controls
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
    • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05470088


Contacts
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Contact: Richard Delorme, M.D, Ph.D +33140032002 richard.delorme@aphp.fr
Contact: Josselin Houenou, M.D, Ph.D +33149813051 josselin.houenou@inserm.fr

Locations
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France
NeuroSpin neuroimaging platforme Not yet recruiting
Gif-sur-Yvette, France, 91191
Contact: Josselin Houenou, MD, PhD       josselin.houenou@inserm.fr   
APHP, Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: Richard Delorme, MD, PhD       richard.delorme@aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
APHP
Institut Pasteur
Commissariat A L'energie Atomique
Investigators
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Principal Investigator: Richard Delorme, M.D, Ph.D APHP, France
Study Chair: Josselin Houenou, M.D, Ph.D Institut National de la Santé Et de la Recherche Médicale, France
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT05470088    
Other Study ID Numbers: C16-90
2017-A02356-47 ( Registry Identifier: IDRCB )
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
neuroimaging
mri
phenotype
heritability
genes
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders