Skip to main content
Clinical Trials/NCT02165410
NCT02165410
Completed
Not Applicable

MRI Study of Cerebral Blood Flow in Development Disorders in Children

Assistance Publique - Hôpitaux de Paris1 site in 1 country115 target enrollmentNovember 13, 2013

Overview

Phase
Not Applicable
Intervention
ASL-MRI
Conditions
Autism
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
115
Locations
1
Primary Endpoint
CBF
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2013
End Date
September 13, 2023
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

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:

Arms & Interventions

Eye tracking and RMI

Intervention: ASL-MRI

Eye tracking and RMI

Intervention: Diffusion tensor imaging (diffusion MRI)

Eye tracking and RMI

Intervention: Resting state MRI

Eye tracking and RMI

Intervention: Eye-tracking

Eye tracking and RMI

Intervention: Cognitive profile

Outcomes

Primary Outcomes

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

  • anatomical connectivity(at Day 0)
  • eye-tracking method(at day 0)

Study Sites (1)

Loading locations...

Similar Trials