MRI Study of Cerebral Blood Flow in Development Disorders in Children (IRM-Aut)

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.

Study Overview

• Status: Completed
• Conditions: Autism
• Intervention / Treatment: Procedure: ASL-MRI; Procedure: Diffusion tensor imaging (diffusion MRI); Procedure: Resting state MRI; Procedure: Eye-tracking; Procedure: Cognitive profile

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 Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75743
    • Hôpital Necker-Enfants Malades Service de Radiologie Pédiatrique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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,
• 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

1. 18 months ≤ age <5 years
2. demand of MRI in the etiologic assessment
3. obtaining written consent from parents or legal guardians.

Very young patients suspected of mental retardation : male and female with suspected mental retardation

1. 18 months ≤ age <5 years
2. demand of MRI in the etiologic assessment
3. obtaining written consent from parents or legal guardians.

All subjects must be registered with the social security.

Exclusion Criteria:

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
• obtaining written consent with parents or legal guardians of volunteers.

All subjects must be registered with the social security.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Eye tracking and RMI

Procedure: ASL-MRI; 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.; Procedure: 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: Resting state MRI; 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.; Procedure: Eye-tracking; 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.; Procedure: Cognitive profile; Children will be asked to perform certain tasks, adapted for their age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Nathalie BODDAERT, MD, PhD, Assistance Publique Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2013
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimated): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Autism, mental retardation, Magnetic Resonance Imaging
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Autistic Disorder; Intellectual Disability; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Diagnostic Techniques, Neurological; Neuroimaging; Magnetic Resonance Imaging; Diffusion Magnetic Resonance Imaging; Diffusion Tensor Imaging
• Other Study ID Numbers: P120204; 2012-A01695-38 (Other Identifier: ANSM)