Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1000 participants
OBSERVATIONAL
2022-03-13
2039-09-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MRI Study of Cerebral Blood Flow in Development Disorders in Children
NCT02165410
MRI Brain (Volumetry, fMRI & MRS) in Autism
NCT05758220
Magnetic Resonance Imaging of Brain Development in Autism
NCT00449566
Brain Imaging in Children With AD/HD
NCT00008892
Advanced MRI in Blast-related TBI
NCT00785304
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Subjects with Autism Spectrum Disorders
Neuroimaging (MRI)
Multimodal magnetic resonance imaging
Relatives of subjects with Autism Spectrum Disorders
Neuroimaging (MRI)
Multimodal magnetic resonance imaging
Typically developing subjects
Neuroimaging (MRI)
Multimodal magnetic resonance imaging
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Neuroimaging (MRI)
Multimodal magnetic resonance imaging
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 all subjects: discovery of a counter indication to MRI during the exam (e.g. claustrophobia)
24 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
APHP
OTHER
Institut Pasteur
INDUSTRY
Commissariat A L'energie Atomique
OTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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
Explore where the study is taking place and check the recruitment status at each participating site.
NeuroSpin neuroimaging platforme
Gif-sur-Yvette, , France
APHP, Hôpital Robert Debré
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-A02356-47
Identifier Type: REGISTRY
Identifier Source: secondary_id
C16-90
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.