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Completed

NCT Number: NCT02165410

MRI Study of Cerebral Blood Flow in Development Disorders in Children

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.

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Key information

Age range

18 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades Service de Radiologie Pédiatrique

Paris, 75743, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

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.

Treatment and study plan

ASL-MRI

Procedure

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

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 MRI

Procedure

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-tracking

Procedure

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 profile

Procedure

Children will be asked to perform certain tasks, adapted for their age.

Primary outcomes

  1. 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

Secondary outcomes

  1. anatomical connectivity

    Time frame: at Day 0

    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.

  2. eye-tracking method

    Time frame: at day 0

    Eye tracking is a non-invasive method that allows objectifying gaze parameters during presentation of stimuli on a computer screen.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: IRM-Aut

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Jun 17, 2014
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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