AutismIRM-AutNCT02165410
MRI Study of Cerebral Blood Flow in Development Disorders in Children
A study testing ASL-MRI, Diffusion tensor imaging (diffusion MRI) and Resting state MRI in people with Autism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is reproduce the individual detection results by PET with Arterial Spin Labeling (ASL) MRI, to establish a biomarker useful in autism diagnosis. Read more about this study
- Who is it for?
- Ages 18 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- ASL-MRI, Diffusion tensor imaging (diffusion MRI) and Resting state MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2013to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient diagnosed autist or suspected autist : males and females with the diagnosis of autism based on the following criteria:
- 5 years ≤ age < 18 years,
- demand for MRI in the etiologic assessment (suspected autism) or MRI control in the treatment (diagnosed with autism)
- obtaining written consent from parents or legal guardians of patients.
- Patients diagnosed with mental retardation or suspected with mental retardation : males and females with the diagnosis of mental retardation using the following criteria:
- 5 years ≤ age < 18 years,
Show all 20Show fewer
- demand for MRI in the etiologic assessment (suspected mental retardation) or MRI control in the treatment (diagnosed with mental retardation)
- obtaining written consent from parents or legal guardians of patients.
- Healthy control subjects: males and females:
- 5 years ≤ age < 18 years
- no known neurological or psychiatric disorder obtaining written consent with parents or legal guardians of volunteers.
- Very young patients suspected of autism: male and female with suspected autism
- 18 months ≤ age <5 years
- demand of MRI in the etiologic assessment
- obtaining written consent from parents or legal guardians.
- Very young patients suspected of mental retardation : male and female with suspected mental retardation
- 18 months ≤ age <5 years
- demand of MRI in the etiologic assessment
- obtaining written consent from parents or legal guardians.
- All subjects must be registered with the social security.
Who cannot join
- For all subjects:
- Indication against performing MRI (pacemaker, an implanted metal foreign body, claustrophobia),
- Inability of healthy volunteers to remain still during the MRI examination.
- Healthy control subjects: males and females:
- aged between 5 years and 18 years
- no known neurological or psychiatric disorder
Show all 11Show fewer
- obtaining written consent with parents or legal guardians of volunteers.
- All subjects must be registered with the social security.
- For all subjects:
- Indication against performing MRI (pacemaker, an implanted metal foreign body, claustrophobia),
- Inability of healthy volunteers to remain still during the MRI examination.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Necker-Enfants Malades Service de Radiologie Pédiatrique
Paris, 75743
About this study
The purpose of this study is reproduce the individual detection results by PET with Arterial Spin Labeling (ASL) MRI, to establish a biomarker useful in autism diagnosis.
Read the detailed description
Anatomical and functional abnormalities have been identified in the superior temporal sulcus (STS) in autism by brain imaging modalities, including positron emission tomography (PET), functional MRI and diffusion MRI. These results suggest that brain imaging abnormalities within the STS could be the first step in the cascade of neuronal abnormalities found in autism.
STS is known as a key area for social cognition and is involved in various stages of social interaction, from visual and auditory perception (perception of eyes, facial and body movements, and perception of human voice) to the more complex process of social cognition (theory of mind, understanding emotions and mentalizing) The anatomical and functional abnormalities within the STS described in autism could account for the social difficulties experienced by persons with autism, both clinically observed and objectified by studies on visual social perception.
The individual detection results found in PET, that is to say a reduction of rCBF in the superior temporal sulcus (STS), could be reproduced with ASL and used to predict the diagnosis of autism in children with the same level of sensitivity and specificity as with PET. The individual detection of decreased rCBF in the STS could be a useful biomarker in autism using MRI, a method more accessible and much less invasive than PET. A MRI biomarker in autism could allow individual analysis, as well as contribute to early diagnosis and objective evaluation of the efficacy of new therapeutic strategies.
The rCBF data measured by MRI-ASL will also be correlated with both clinical (Autism Diagnostic Interview - ADI-R) and behavioral data of the social perception measured by the eye-tracking method. In addition, we will study the impact of these temporal anomalies on brain connectivity MRI method of diffusion tensor. We will also describe the abnormalities present in the very early development of autism.
- Conditions
- Autism
- Being tested
- ASL-MRI, Diffusion tensor imaging (diffusion MRI), Resting state MRI, Eye-tracking, Cognitive profile
- Keywords
- Autism, mental retardation, Magnetic Resonance Imaging
- Medical subject headings
- Autistic Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASL-MRIProcedure or surgery
ASL MRI is a non-invasive technique without injection to measure rCBF at rest marking the intravascular water molecules and use it as an endogenous tracer. Premedication, if required, will concern autistic and mentally retarded subjects only.
Diffusion tensor imaging (diffusion MRI)Procedure or surgery
Diffusion MRI enables the mapping of the diffusion process of water molecules, which allows visualizing anatomical connections between different parts of the brain, noninvasively and on an individual basis. The sequence is acquired following clinical MRI sequences, while the child is still inside the MRI machine, with no further intervention applied.
Resting state MRIProcedure or surgery
This sequence is based on the synchronization of fluctuations in the blood-oxygen level dependent (BOLD) signal of different brain regions that work as a network. Therefore this sequence allows for the establishing of maps of funcitonal connectivity.
Eye-trackingProcedure or surgery
Eye tracking is a non-invasive method that allows objectifying gaze parameters during presentation of stimuli on a computer screen. Children will be presented with a series of social and no social stimuli and are required to watch it, with no further intervention applied.
Cognitive profileProcedure or surgery
Children will be asked to perform certain tasks, adapted for their age.
| Study group | Role | What they receive |
|---|---|---|
| Eye tracking and RMI | Experimental | Not described Receives: Procedure: ASL-MRI; Procedure: Diffusion tensor imaging (diffusion MRI); Procedure: Resting state MRI; Procedure: Eye-tracking; Procedure: Cognitive profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBF
ASL is an MRI technique to measure CBF at rest by labeling arterial intravascular water and use as an endogenous tracer. This sequence is performed without injection of contrast or injection of radioactivity
Measured: at day 0
Secondary outcomes (2)
anatomical connectivity
Diffusion tensor MRI (DTI) enables the mapping of the diffusion process of water molecules, which allows visualizing anatomical connections between different parts of the brain, noninvasively and on an individual basis.
Measured: at Day 0
eye-tracking method
Eye tracking is a non-invasive method that allows objectifying gaze parameters during presentation of stimuli on a computer screen.
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study start13 Nov 2013
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
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
- Nathalie BODDAERT, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165410
- Sponsor's protocol ID
- P120204
- Other IDs
- 2012-A01695-38
- Acronym
- IRM-Aut
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2014
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Rechtman E, Puget S, Saitovitch A, Lemaitre H, Fillion L, Tacchella JM, Boisgontier J, Cuny ML, Boddaert N, Zilbovicius M. Posterior Fossa Arachnoid Cyst in a Pediatric Population is Associated with Social Perception and Rest Cerebral Blood Flow Abnormalities. Cerebellum. 2020 Feb;19(1):58-67. doi: 10.1007/s12311-019-01082-w.
PubMed 31732920Vincon-Leite A, Saitovitch A, Lemaitre H, Rechtman E, Fillon L, Grevent D, Calmon R, Brunelle F, Boddaert N, Zilbovicius M. Neural basis of interindividual variability in social perception in typically developing children and adolescents using diffusion tensor imaging. Sci Rep. 2020 Apr 14;10(1):6379. doi: 10.1038/s41598-020-63273-4.
PubMed 32286406Vincon-Leite A, Saitovitch A, Lemaitre H, Rechtman E, Boisgontier J, Fillon L, Philippe A, Rio M, Desguerre I, Fabre A, Aljabali K, Boddaert N, Zilbovicius M. Identifying interindividual variability of social perception and associated brain anatomical correlations in children with autism spectrum disorder using eye-tracking and diffusion tensor imaging MRI (DTI-MRI). Cereb Cortex. 2024 Jan 14;34(1):bhad434. doi: 10.1093/cercor/bhad434.
PubMed 38037470
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Study of Cerebral Blood Flow in Development Disorders in Children
- ClinicalTrials.gov ID
- NCT02165410
- Acronym / sponsor ID
- IRM-Aut / P120204
- Conditions
- Autism
- Keywords
- Autism, mental retardation, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 13 Nov 2013 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 17 Jun 2014 (estimated)
- 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 purpose of this study is reproduce the individual detection results by PET with Arterial Spin Labeling (ASL) MRI, to establish a biomarker useful in autism diagnosis.
Detailed description
Anatomical and functional abnormalities have been identified in the superior temporal sulcus (STS) in autism by brain imaging modalities, including positron emission tomography (PET), functional MRI and diffusion MRI. These results suggest that brain imaging abnormalities within the STS could be the first step in the cascade of neuronal abnormalities found in autism.
STS is known as a key area for social cognition and is involved in various stages of social interaction, from visual and auditory perception (perception of eyes, facial and body movements, and perception of human voice) to the more complex process of social cognition (theory of mind, understanding emotions and mentalizing) The anatomical and functional abnormalities within the STS described in autism could account for the social difficulties experienced by persons with autism, both clinically observed and objectified by studies on visual social perception.
The individual detection results found in PET, that is to say a reduction of rCBF in the superior temporal sulcus (STS), could be reproduced with ASL and used to predict the diagnosis of autism in children with the same level of sensitivity and specificity as with PET. The individual detection of decreased rCBF in the STS could be a useful biomarker in autism using MRI, a method more accessible and much less invasive than PET. A MRI biomarker in autism could allow individual analysis, as well as contribute to early diagnosis and objective evaluation of the efficacy of new therapeutic strategies.
The rCBF data measured by MRI-ASL will also be correlated with both clinical (Autism Diagnostic Interview - ADI-R) and behavioral data of the social perception measured by the eye-tracking method. In addition, we will study the impact of these temporal anomalies on brain connectivity MRI method of diffusion tensor. We will also describe the abnormalities present in the very early development of autism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eye tracking and RMI | Experimental | Procedure: ASL-MRI, Procedure: Diffusion tensor imaging (diffusion MRI), Procedure: Resting state MRI, Procedure: Eye-tracking, Procedure: Cognitive profile |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Patient diagnosed autist or suspected autist : males and females with the diagnosis of autism based on the following criteria:
- 5 years ≤ age < 18 years,
- demand for MRI in the etiologic assessment (suspected autism) or MRI control in the treatment (diagnosed with autism)
- obtaining written consent from parents or legal guardians of patients.
- Patients diagnosed with mental retardation or suspected with mental retardation : males and females with the diagnosis of mental retardation using the following criteria:
Key exclusion criteria (11 listed)
- Indication against performing MRI (pacemaker, an implanted metal foreign body, claustrophobia),
- Inability of healthy volunteers to remain still during the MRI examination.
- aged between 5 years and 18 years
- no known neurological or psychiatric disorder
- obtaining written consent with parents or legal guardians of volunteers.
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 |
|---|---|---|
| ASL-MRIASL MRI is a non-invasive technique without injection to measure rCBF at rest marking the intravascular water molecules and use it as an endogenous tracer. Premedication, if required, will concern autistic and mentally retarded subjects only. | Procedure or surgery | Eye tracking and RMI |
| Diffusion tensor imaging (diffusion MRI)Diffusion MRI enables the mapping of the diffusion process of water molecules, which allows visualizing anatomical connections between different parts of the brain, noninvasively and on an individual basis. The sequence is acquired following clinical MRI sequences, while the child is still inside the MRI machine, with no further intervention applied. | Procedure or surgery | Eye tracking and RMI |
| Resting state MRIThis sequence is based on the synchronization of fluctuations in the blood-oxygen level dependent (BOLD) signal of different brain regions that work as a network. Therefore this sequence allows for the establishing of maps of funcitonal connectivity. | Procedure or surgery | Eye tracking and RMI |
| Eye-trackingEye tracking is a non-invasive method that allows objectifying gaze parameters during presentation of stimuli on a computer screen. Children will be presented with a series of social and no social stimuli and are required to watch it, with no further intervention applied. | Procedure or surgery | Eye tracking and RMI |
| Cognitive profileChildren will be asked to perform certain tasks, adapted for their age. | Procedure or surgery | Eye tracking and RMI |
Primary outcome
CBF
Time frame: at day 0
ASL is an MRI technique to measure CBF at rest by labeling arterial intravascular water and use as an endogenous tracer. This sequence is performed without injection of contrast or injection of radioactivity
2 secondary outcomes
anatomical connectivity
Time frame: at Day 0
eye-tracking method
Time frame: at day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Results publication: PubMed 31732920Rechtman E, Puget S, Saitovitch A, Lemaitre H, Fillion L, Tacchella JM, Boisgontier J, Cuny ML, Boddaert N, Zilbovicius M. Posterior Fossa Arachnoid Cyst in a Pediatric Population is Associated with Social Perception and Rest Cerebral Blood Flow Abnormalities. Cerebellum. 2020 Feb;19(1):58-67. doi: 10.1007/s12311-019-01082-w.
- Results publication: PubMed 32286406Vincon-Leite A, Saitovitch A, Lemaitre H, Rechtman E, Fillon L, Grevent D, Calmon R, Brunelle F, Boddaert N, Zilbovicius M. Neural basis of interindividual variability in social perception in typically developing children and adolescents using diffusion tensor imaging. Sci Rep. 2020 Apr 14;10(1):6379. doi: 10.1038/s41598-020-63273-4.
- Results publication: PubMed 38037470Vincon-Leite A, Saitovitch A, Lemaitre H, Rechtman E, Boisgontier J, Fillon L, Philippe A, Rio M, Desguerre I, Fabre A, Aljabali K, Boddaert N, Zilbovicius M. Identifying interindividual variability of social perception and associated brain anatomical correlations in children with autism spectrum disorder using eye-tracking and diffusion tensor imaging MRI (DTI-MRI). Cereb Cortex. 2024 Jan 14;34(1):bhad434. doi: 10.1093/cercor/bhad434.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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. This study is not recruiting at the moment.
Nathalie BODDAERT, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASL-MRI, Diffusion tensor imaging (diffusion MRI) and Resting state MRI in people with Autism, 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 20 inclusion and 11 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: finished, as of the sponsor's last update on 21 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBF (time frame: at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02165410, which also lists 3 linked publications.
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 21 Aug 2026.