MRI Study of Cerebral Blood Flow in Development Disorders in Children

NCT ID: NCT02165410

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-13
• Study Completion Date: 2023-09-13

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Eye tracking and RMI

Group Type: EXPERIMENTAL

ASL-MRI

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Cognitive profile

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie BODDAERT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades Service de Radiologie Pédiatrique

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nathalie BODDAERT, MD, PhD

Role: CONTACT

nathalie.boddaert@nck.aphp.fr

00 33 1 44 49 51 71

Laure CHOUPEUX, MSc

Role: CONTACT

laure.choupeaux@aphp.fr

00 33 1 44 38 17 11

Facility Contacts

Nathalie Boddaert, PhD

Role: primary

nathalie.boddaert@nck.aphp.fr

00 33 1 44 49 51 71

Other Identifiers

2012-A01695-38

Identifier Type: OTHER

Identifier Source: secondary_id

P120204

Identifier Type: -

Identifier Source: org_study_id