Recruiting NCT05470088

MRI Study of Subjects with ASD, Their Relatives and TD

— Observational Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Neuroimaging (MRI).
Who it may be relevant to: Registry conditions: Autism Spectrum Disorder. Basic parameters: from 24 months · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

Other Neuroimaging (MRI)
Multimodal magnetic resonance imaging

Primary outcome measures

3DT1 MRI derived variables [Time frame: Day 0]
Resting state fMRI derived variables [Time frame: Day 0]
Task based fMRI derived variables [Time frame: Day 0]
Diffusion MRI derived variables [Time frame: Day 0]
quantitative T1 and quantitative T2 MRI [Time frame: Day 0]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model: Case-control

Study locations

France · 2 centers

NeuroSpin neuroimaging platforme — Gif-sur-Yvette
APHP, Hôpital Robert Debré — Paris

Identifiers

NCT: NCT05470088 · C16-90 · 2017-A02356-47

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗