MRI Study of Subjects with ASD, Their Relatives and TD
Magnetic Resonance Imaging Neuroanatomical Study of Patients with an Autism Spectrum Disorder, Their Relatives and Typically Developing Subjects.
2 other identifiers
observational
1,000
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2022
CompletedFirst Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 13, 2039
March 13, 2025
March 1, 2025
15 years
July 20, 2022
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
3DT1 MRI derived variables
Cortical folding Cortical thickness Cortical surface Cortical, white matter and subcortical volumes
Day 0
Resting state fMRI derived variables
Whole-brain BOLD signal correlations
Day 0
Task based fMRI derived variables
BOLD activation signals BOLD signal correlations
Day 0
Diffusion MRI derived variables
Fractional anisotropy and mean diffusivity NODDI derived variables
Day 0
quantitative T1 and quantitative T2 MRI
Myelin Water Fraction
Day 0
Study Arms (3)
Subjects with Autism Spectrum Disorders
Relatives of subjects with Autism Spectrum Disorders
Typically developing subjects
Interventions
Multimodal magnetic resonance imaging
Eligibility Criteria
Three groups of subjects above 24 months (no upper limit of age): * subjects with ASD * relatives of subjects with ASD * typically developing controls
You may qualify if:
- 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
- +11 more criteria
You may not qualify if:
- for all subjects: discovery of a counter indication to MRI during the exam (e.g. claustrophobia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut National de la Santé Et de la Recherche Médicale, Francelead
- APHPcollaborator
- Institut Pasteurcollaborator
- Commissariat A L'energie Atomiquecollaborator
Study Sites (2)
NeuroSpin neuroimaging platforme
Gif-sur-Yvette, 91191, France
APHP, Hôpital Robert Debré
Paris, 75019, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 22, 2022
Study Start
March 13, 2022
Primary Completion (Estimated)
March 13, 2037
Study Completion (Estimated)
September 13, 2039
Last Updated
March 13, 2025
Record last verified: 2025-03