MRI Study of Cerebral Blood Flow in Development Disorders in Children

Autism Clinical Trial

— IRM-Aut  

Official title:

MRI Study of Cerebral Blood Flow in Development Disorders in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02165410
• Other study ID #: P120204
• Secondary ID: 2012-A01695-38
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2013
• Est. completion date: September 13, 2023

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nathalie BODDAERT, MD, PhD
• Phone: 00 33 1 44 49 51 71
• Email: nathalie.boddaert[@]nck.aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades Service de Radiologie Pédiatrique	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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