MRI analysis of individuals with autism and their families
Magnetic Resonance Imaging Neuroanatomical Study of Patients with an Autism Spectrum Disorder, Their Relatives and Typically Developing Subjects.
This study is trying to see if brain scans can help us understand the genetic and clinical features of autism in people with the condition and their families.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 24 Months and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 2 sites (Gif-sur-Yvette and 1 other locations) |
| Trial ID | NCT05470088 on ClinicalTrials.gov |
What this trial studies
This project focuses on understanding the genetic and clinical aspects of Autism Spectrum Disorder (ASD) through neuroimaging techniques. It involves acquiring anatomical, diffusion, and functional MRI data from individuals diagnosed with ASD, their relatives, and control subjects. The study is part of a larger initiative examining genetic factors associated with ASD, leveraging data from over 600 previously recruited participants. The research aims to identify brain abnormalities linked to ASD and their heritability.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with ASD who are part of the main genetic study and are at least 24 months old.
Not a fit: Patients who do not meet the diagnostic criteria for ASD or are not part of the main genetic study may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of the neurobiological underpinnings of autism, potentially leading to improved diagnostic and therapeutic strategies.
How similar studies have performed: Previous studies utilizing neuroimaging to explore ASD have shown promising results, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Gif-sur-Yvette and 1 other locations
- NeuroSpin neuroimaging platforme — Gif-sur-Yvette, France (Not_yet_recruiting)
- APHP, Hôpital Robert Debré — Paris, France (Recruiting)
Study contacts
- Principal investigator: Richard Delorme, M.D, Ph.D — APHP, France
- Study coordinator: Richard Delorme, M.D, Ph.D
- Email: richard.delorme@aphp.fr
- Phone: +33140032002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.