MRI Study of Subjects With ASD, Their Relatives and TD

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470088
• Other study ID #: C16-90
• Secondary ID: 2017-A02356-47
• Status: Recruiting
• Start date: March 13, 2022
• Est. completion date: September 13, 2039

Study information

• Verified date: August 2022
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Richard Delorme, M.D, Ph.D
• Phone: +33140032002
• Email: richard.delorme[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 13, 2039
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months and older

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Other:
• Neuroimaging (MRI)
Multimodal magnetic resonance imaging

Locations

Country	Name	City	State
France	NeuroSpin neuroimaging platforme	Gif-sur-Yvette
France	APHP, Hôpital Robert Debré	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	APHP, Commissariat A L'energie Atomique, Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3DT1 MRI derived variables	Cortical folding Cortical thickness Cortical surface Cortical, white matter and subcortical volumes	Day 0
Primary	Resting state fMRI derived variables	Whole-brain BOLD signal correlations	Day 0
Primary	Task based fMRI derived variables	BOLD activation signals BOLD signal correlations	Day 0
Primary	Diffusion MRI derived variables	Fractional anisotropy and mean diffusivity NODDI derived variables	Day 0
Primary	quantitative T1 and quantitative T2 MRI	Myelin Water Fraction	Day 0