NCT05470088Recruiting
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.
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 20 Jul 2022
- Start date
- 13 Mar 2022
- Primary completion date
- 13 Mar 2037
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Autism
- NCT number
- NCT05470088
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 13 Mar 2022 to the primary completion date, 13 Mar 2037
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 24 months to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NeuroSpin neuroimaging platforme Coordinator of this site? Confirm its status | Gif-sur-Yvette | France | Not yet recruiting |
| APHP Hôpital Robert Debré Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.