Autism Spectrum DisorderECLATNCT06334588
Understanding the Mechanisms of Autism : an MRI and Social Cognition Study
A study testing MRI, Eye-tracking and Clinical Scales in people with Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking Read more about this study
- Who is it for?
- Ages 3 months to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- MRI, Eye-tracking and Clinical Scales
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2024to Apr 2031
- Phase
- Interventional
- 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 3 months to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For subjects diagnosed with ASD or suspected of ASD :
- 3 months ≤ age < 25 years ;
- an MRI required as part of the clinical procedures
- written consent obtained from parents or legal guardians.
- Affiliated to social security
- For Healthy control subjects over 3 years of age:
Show all 15Show fewer
- between 3 and 28 years of age
- no known neurological or psychiatric pathology
- written consent obtained from parents or legal guardian.
- Affiliated to social security
- For Healthy control subjects under 5 years of age:
- age between 3 months and 5 years
- who have had an MRI scan in the pediatric radiology department at Necker Hospital, which was found to be normal.
- with no known neurological or psychiatric pathology
- no opposition from legal representative
Who cannot join
- Contraindication to MRI (pacemaker, intracorporeal metallic body, claustrophobia).
- Impossibility for healthy volunteers to remain still during MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker Enfants Malades
Paris, 75015
Nathalie BODDAERT, MD, PhD, +33 1.71.39.65.30, nathalie.boddaert@aphp.fr
About this study
The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking
Read the detailed description
Autism Spectrum Disorders (ASD) are neurodevelopmental disorders whose first manifestations appear early in childhood. Even if ASDs present a wide heterogeneity in clinical manifestations, abnormalities in social behavior, characterized in particular by a lack of preference for social information, remain the core of difficulties characteristic of autism.
Brain imaging investigations have revealed anatomo-functional abnormalities in autism, particularly in social brain regions. In parallel, eye-tracking studies have provided objective measures of social perception abnormalities in autism. These results illustrate the relevance of these research strategies in the context of ASD. Acquiring objective data on social behavior and linking them with brain imaging data opens up new avenues for research into the evolution of social skills during child development, and the brain changes underlying this process.
In this context, the main hypothesis of this study is that the investigation of the neural bases of autism spectrum disorders, using an approach combining multimodal brain imaging and the investigation of social behavior using eye-tracking, would make it possible not only to better describe abnormalities, but also to identify individual patterns at brain and behavioral level. This could help to better characterize ASDs with and without genetic abnormalities, an area which to date has received very little investigation. In addition, the objective measurements obtained with this approach would also enable the proposal of biomarkers, which would contribute not only to better monitoring of the disorder's evolution, but also to the evaluation of the effectiveness of new therapeutic interventions
- Conditions
- Autism Spectrum Disorder
- Being tested
- MRI, Eye-tracking, Clinical Scales, Research of genetic anomalies
- Keywords
- Autism spectrum disorders, Multimodal brain imaging, Eye-tracking, Social perception, Genetics, Developmental trajectory
- 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.
MRIDiagnostic test
Anatomical and functional images will be acquired and review by an experienced neuro-radiologist
Eye-trackingDevice
Eye movements and follow a person's gaze will be recorded during visualization of stimuli presented in the screen by analyzing images of the eye captured by an infrared camera
Clinical ScalesOther
CGI, E-CAR and ABC will be used for behavior and clinical evaluation
Research of genetic anomaliesGenetic
For the diagnosis of autism, patients benefit from a a genetic assessment. This is carried out as part of their care
| Study group | Role | What they receive |
|---|---|---|
| Suspected or confirmed Autism Spectrum Disorders (ASD) | Experimental | Patient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care Receives: Diagnostic Test: MRI; Device: Eye-tracking; Other: Clinical Scales; Genetic: Research of genetic anomalies |
| Healthy volunteers over 3 years of age | Experimental | Healthy Control Children will be recruited specifically for the research Receives: Diagnostic Test: MRI; Device: Eye-tracking; Other: Clinical Scales |
| Healthy volunteers under 5 years of age | No intervention | Children who have already undergone an MRI for various medical reasons and whose MRI was normal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rest cerebral blood flow (CBF)
Whole brain rest CBF measured with Arterial spin labelling MRI
Measured: at inclusion
Secondary outcomes (13)
Measurements of white matter microstructure - fractional anisotropy
Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by fractional anisotropy (indicates the orientation of diffusion)
Measured: at inclusion
Measurements of white matter microstructure - mean diffusivity
Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by mean diffusivity (the mean amount of diffusion in each of the principal directions calculated in the tensor
Measured: at inclusion
Measurements of white matter microstructure - radial diffusivity
Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by radial diffusivity (the apparent water diffusion coefficient in the direction perpendicular to the axonal fibers)
Measured: at inclusion
Measurements of white matter microstructure - axial diffusivity
Measurements of white matter microstructure integrity by diffusion tensor imaging MRI, measured by axial diffusivity (the magnitude of diffusion parallel to fiber tracts)
Measured: at inclusion
Measurements of resting state functional connectivity
MRI-resting state measurements of correlation coefficients between different regions within different brain networks, in particular the social brain network.
Measured: at inclusion
Correlation between social perception and multimodal brain imaging
Correlation measurements between social perception parameters measured by eye-tracking (number of fixations in social and non-social regions) and various multimodal brain imaging parameters obtained with MRI.
Measured: at inclusion
Correlation between clinical severity and multimodal brain imaging
Measures of correlation between autism severity scores measured by the ADI-R and various multimodal brain imaging parameters obtained in MRI
Measured: at inclusion
Imaging abnormalities associated with known genetic mutations
Multimodal brain imaging in patients with a known genetic abnormality compared with the same measures obtained in patients without known genetic abnormalities or in healthy controls.
Measured: at inclusion
Social perception abnormalities associated with known genetic mutations
Social perception measures (number of fixations in social and non-social regions) in patients with a known genetic abnormality compared with the same measures obtained in patients without known genetic abnormalities or in healthy controls.
Measured: at inclusion
Anatomic changes over time - study of developmental trajectory
Measures of change over time (between inclusion and 2 years) in brain anatomy and function in a subgroup of ASD patients and healthy volunteers.
Measured: 2 years
Social perception changes over time - study of developmental trajectory
Measures of change over time (between inclusion and 2 years) in social perception parameters in a subgroup of ASD patients and healthy volunteers.
Measured: 2 years
Brain imaging in young children associated with ASD
Multimodal brain imaging measures in young patients (<5 years) with a ASD compared with the same measures obtained in young children (<5 years) without ASD (control children)
Measured: at inclusion
Early data on social perception
Social perception measures (number of fixations in social and non-social regions) in very young patients with ASD (3 months to 5 years) compared with a subgroup of control children aged under 5 years
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start17 Apr 2024
- Primary completionApr 2029 (estimated)
- Study completionApr 2031 (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 Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Monica ZILBOVICIUS, Study director, INSERM INSERM ERL "Trajectoires Développementales en Psychiatrie"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334588
- Sponsor's protocol ID
- APHP240105
- Other IDs
- 2023-A02668-37
- Acronym
- ECLAT
- Status last verified
- Dec 2025
- First submitted
- 22 Feb 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Mechanisms of Autism : an MRI and Social Cognition Study
- ClinicalTrials.gov ID
- NCT06334588
- Acronym / sponsor ID
- ECLAT / APHP240105
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorders, Multimodal brain imaging, Eye-tracking, Social perception, Genetics, Developmental trajectory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 28 Mar 2024 (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.
The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking
Detailed description
Autism Spectrum Disorders (ASD) are neurodevelopmental disorders whose first manifestations appear early in childhood. Even if ASDs present a wide heterogeneity in clinical manifestations, abnormalities in social behavior, characterized in particular by a lack of preference for social information, remain the core of difficulties characteristic of autism.
Brain imaging investigations have revealed anatomo-functional abnormalities in autism, particularly in social brain regions. In parallel, eye-tracking studies have provided objective measures of social perception abnormalities in autism. These results illustrate the relevance of these research strategies in the context of ASD. Acquiring objective data on social behavior and linking them with brain imaging data opens up new avenues for research into the evolution of social skills during child development, and the brain changes underlying this process.
In this context, the main hypothesis of this study is that the investigation of the neural bases of autism spectrum disorders, using an approach combining multimodal brain imaging and the investigation of social behavior using eye-tracking, would make it possible not only to better describe abnormalities, but also to identify individual patterns at brain and behavioral level. This could help to better characterize ASDs with and without genetic abnormalities, an area which to date has received very little investigation. In addition, the objective measurements obtained with this approach would also enable the proposal of biomarkers, which would contribute not only to better monitoring of the disorder's evolution, but also to the evaluation of the effectiveness of new therapeutic interventions
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suspected or confirmed Autism Spectrum Disorders (ASD) | Experimental | Diagnostic Test: MRI, Device: Eye-tracking, Other: Clinical Scales, Genetic: Research of genetic anomaliesPatient with ASD or suspected ASD for whom an MRI is requested by the clinician as part of care |
| Healthy volunteers over 3 years of age | Experimental | Diagnostic Test: MRI, Device: Eye-tracking, Other: Clinical ScalesHealthy Control Children will be recruited specifically for the research |
| Healthy volunteers under 5 years of age | No intervention | –Children who have already undergone an MRI for various medical reasons and whose MRI was normal. |
Who may qualify
- Ages
- 3 months to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 3 months ≤ age < 25 years ;
- an MRI required as part of the clinical procedures
- written consent obtained from parents or legal guardians.
- Affiliated to social security
- between 3 and 28 years of age
Key exclusion criteria (2 listed)
- Contraindication to MRI (pacemaker, intracorporeal metallic body, claustrophobia).
- Impossibility for healthy volunteers to remain still during MRI
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 |
|---|---|---|
| MRIAnatomical and functional images will be acquired and review by an experienced neuro-radiologist | Diagnostic test | Healthy volunteers over 3 years of age, Suspected or confirmed Autism Spectrum Disorders (ASD) |
| Eye-trackingEye movements and follow a person's gaze will be recorded during visualization of stimuli presented in the screen by analyzing images of the eye captured by an infrared camera | Device | Healthy volunteers over 3 years of age, Suspected or confirmed Autism Spectrum Disorders (ASD) |
| Clinical ScalesCGI, E-CAR and ABC will be used for behavior and clinical evaluation | Other | Healthy volunteers over 3 years of age, Suspected or confirmed Autism Spectrum Disorders (ASD) |
| Research of genetic anomaliesFor the diagnosis of autism, patients benefit from a a genetic assessment. This is carried out as part of their care | Genetic | Suspected or confirmed Autism Spectrum Disorders (ASD) |
Primary outcome
Rest cerebral blood flow (CBF)
Time frame: at inclusion
Whole brain rest CBF measured with Arterial spin labelling MRI
13 secondary outcomes
Measurements of white matter microstructure - fractional anisotropy
Time frame: at inclusion
Measurements of white matter microstructure - mean diffusivity
Time frame: at inclusion
Measurements of white matter microstructure - radial diffusivity
Time frame: at inclusion
Measurements of white matter microstructure - axial diffusivity
Time frame: at inclusion
Measurements of resting state functional connectivity
Time frame: at inclusion
Correlation between social perception and multimodal brain imaging
Time frame: at inclusion
Correlation between clinical severity and multimodal brain imaging
Time frame: at inclusion
Imaging abnormalities associated with known genetic mutations
Time frame: at inclusion
Social perception abnormalities associated with known genetic mutations
Time frame: at inclusion
Anatomic changes over time - study of developmental trajectory
Time frame: 2 years
Social perception changes over time - study of developmental trajectory
Time frame: 2 years
Brain imaging in young children associated with ASD
Time frame: at inclusion
Early data on social perception
Time frame: at inclusion
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 23 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Monica ZILBOVICIUS study director
INSERM INSERM ERL "Trajectoires Développementales en Psychiatrie"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, Eye-tracking and Clinical Scales in people with Autism Spectrum Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 15 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Nathalie BODDAERT, MD, PhD (+33 1.71.39.65.30, nathalie.boddaert@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rest cerebral blood flow (CBF) (time frame: at inclusion). 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 23 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.