MRI Study of Cerebral Blood Flow in Development Disorders in Children

NCT02165410 | Completed

• 2 other identifiers: P1202042012-A01695-38
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

Autism, mental retardation, Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• anatomical connectivity

  at Day 0

• eye-tracking method

  at day 0

Study Arms (1)

Eye tracking and RMI

EXPERIMENTAL

Procedure: ASL-MRI; Procedure: Diffusion tensor imaging (diffusion MRI); Procedure: Resting state MRI; Procedure: Eye-tracking; Procedure: Cognitive profile

Interventions

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.

Eye tracking and RMI

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.

Eye tracking and RMI

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 and RMI

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.

Eye tracking and RMI

Cognitive profile PROCEDURE

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

Eye tracking and RMI

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient diagnosed autist or suspected autist : males and females with the diagnosis of autism based on the following criteria:
• 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:
• 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:
• 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
• months ≤ age \<5 years
• demand of MRI in the etiologic assessment
• obtaining written consent from parents or legal guardians.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades Service de Radiologie Pédiatrique

Paris, 75743, France

Location

MeSH Terms

Conditions

Autistic Disorder; Intellectual Disability

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Nathalie BODDAERT, MD, PhD

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: June 17, 2014
• Study Start: November 13, 2013
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

FR (1)