Autism Spectrum DisorderNCT05470088
MRI Study of Subjects with ASD, Their Relatives and TD
An observational study of Autism Spectrum Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 24 months and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Neuroimaging (MRI)
- How many people
- 1,000 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Mar 2022to 13 Sep 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Three groups of subjects above 24 months (no upper limit of age): * subjects with ASD * relatives of subjects with ASD * typically developing controls
Who may be able to join
- 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)
Show all 28Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
NeuroSpin neuroimaging platforme
Gif-sur-Yvette, 91191
Josselin Houenou, MD, PhD, josselin.houenou@inserm.fr
- Recruiting
APHP, Hôpital Robert Debré
Paris, 75019
Richard Delorme, MD, PhD, richard.delorme@aphp.fr
About this study
Official title: Magnetic Resonance Imaging Neuroanatomical Study of Patients with an Autism Spectrum Disorder, Their Relatives and Typically Developing Subjects.
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.
Read more
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
- Conditions
- Autism Spectrum Disorder
- Being tested
- Neuroimaging (MRI)
- Keywords
- neuroimaging, mri, phenotype, heritability, genes
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroimaging (MRI)Other
Multimodal magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Autism Spectrum Disorders | Not described Receives: Other: Neuroimaging (MRI) | |
| Relatives of subjects with Autism Spectrum Disorders | Not described Receives: Other: Neuroimaging (MRI) | |
| Typically developing subjects | Not described Receives: Other: Neuroimaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3DT1 MRI derived variables
Cortical folding Cortical thickness Cortical surface Cortical, white matter and subcortical volumes
Measured: Day 0
Resting state fMRI derived variables
Whole-brain BOLD signal correlations
Measured: Day 0
Task based fMRI derived variables
BOLD activation signals BOLD signal correlations
Measured: Day 0
Diffusion MRI derived variables
Fractional anisotropy and mean diffusivity NODDI derived variables
Measured: Day 0
quantitative T1 and quantitative T2 MRI
Myelin Water Fraction
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start13 Mar 2022
- Primary completion13 Mar 2037 (estimated)
- Study completion13 Sep 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- APHP, Institut Pasteur, Commissariat A L'energie Atomique
- Responsible party
- Sponsor
- Investigators
- Richard Delorme, M.D, Ph.D, Principal investigator, APHP, FranceJosselin Houenou, M.D, Ph.D, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470088
- Sponsor's protocol ID
- C16-90
- Other IDs
- 2017-A02356-47
- Status last verified
- Mar 2025
- First submitted
- 20 Jul 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Neuroanatomical Study of Patients with an Autism Spectrum Disorder, Their Relatives and Typically Developing Subjects.
- ClinicalTrials.gov ID
- NCT05470088
- Acronym / sponsor ID
- C16-90
- Conditions
- Autism Spectrum Disorder
- Keywords
- neuroimaging, mri, phenotype, heritability, genes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- APHP, Institut Pasteur, Commissariat A L'energie Atomique
- Study start
- 13 Mar 2022 (actual)
- Primary completion
- 13 Mar 2037 (estimated)
- Study completion
- 13 Sep 2039 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with Autism Spectrum Disorders | – | Other: Neuroimaging (MRI) |
| Relatives of subjects with Autism Spectrum Disorders | – | Other: Neuroimaging (MRI) |
| Typically developing subjects | – | Other: Neuroimaging (MRI) |
Who may qualify
- Ages
- 24 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three groups of subjects above 24 months (no upper limit of age): * subjects with ASD * relatives of subjects with ASD * typically developing controls
Key inclusion criteria (28 listed)
- for patients:
- for relatives
- for controls
- for all subjects
- for the relatives
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroimaging (MRI)Multimodal magnetic resonance imaging | Other | Relatives of subjects with Autism Spectrum Disorders, Subjects with Autism Spectrum Disorders, Typically developing subjects |
Primary outcome
3DT1 MRI derived variables
Time frame: Day 0
Cortical folding Cortical thickness Cortical surface Cortical, white matter and subcortical volumes
Resting state fMRI derived variables
Time frame: Day 0
Whole-brain BOLD signal correlations
Task based fMRI derived variables
Time frame: Day 0
BOLD activation signals BOLD signal correlations
Diffusion MRI derived variables
Time frame: Day 0
Fractional anisotropy and mean diffusivity NODDI derived variables
quantitative T1 and quantitative T2 MRI
Time frame: Day 0
Myelin Water Fraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Delorme, M.D, Ph.D principal investigator
APHP, France
Josselin Houenou, M.D, Ph.D study chair
Institut National de la Santé Et de la Recherche Médicale, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Delorme, M.D, Ph.D (+33140032002, richard.delorme@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3DT1 MRI derived variables (time frame: Day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.