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Build-up of Action Representation in Autism Spectrum Disorders (ASD-BARN)

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ClinicalTrials.gov Identifier: NCT03108976
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Autistic spectrum disorders (ASD) are highly debilitating developmental syndromes which core feature is social and communications disorders. Motor skill impairments are frequently described in autism, but few studies have addressed the question of their origin and their specificity. Furthermore, it is not clear whether motor problems encountered in autism are related to dyspraxia, or if they present with specific features. This project aims at deciphering the origin of motor problems encountered by children who grow-up with autism in order to propose early interventions that could influence the other developmental trajectories, such as the social one.

Brain dynamics during sensori-motor learning is explored by applying magnetoencephalography (MEG) during the Bimanual Load-Lifting paradigm. Different motor processes namely: proprioceptive monitoring, use and update of a sensori-motor representation, anticipatory executive control will be correlated to brain oscillation modulation, both topographically and temporally. Two groups of children (aged between 7 and 12) are compared: a group of children with ASD and a control group of typically developing children.


Condition or disease Intervention/treatment Phase
Healthy Autism Spectrum Disorder Other: Behavioral assessments Other: Magnetoencephalography (MEG) Other: Magnetic Resonance Imaging (MRI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Build-up of Action Representation During Neurodevelopment: Dysfunctions in Autism Spectrum Disorders?
Actual Study Start Date : April 10, 2015
Estimated Primary Completion Date : March 10, 2019
Estimated Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Control group
Children with a typical development.
Other: Behavioral assessments
Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).

Other: Magnetoencephalography (MEG)
Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).

Other: Magnetic Resonance Imaging (MRI)
Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).

Active Comparator: Case group
Children with Autism Spectrum Disorders.
Other: Behavioral assessments
Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).

Other: Magnetoencephalography (MEG)
Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).

Other: Magnetic Resonance Imaging (MRI)
Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).




Primary Outcome Measures :
  1. Changes of cerebral oscillations in three frequency bands (alpha, beta, gamma) during sensori-motor learning. [ Time Frame: Day 1 ]
    Oscillatory measures are computed in the sensor and source space in order to identify the regions involved in the sensori-motor learning in the control group and in the ASD group.


Secondary Outcome Measures :
  1. Correlation between oscillatory measures and learning performance. [ Time Frame: Day 1 ]
    Kinematic recordings enable to measure the learning performance at the end of the experiment. This measure will be correlated with oscillatory changes during the task.



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Control group: children aged between 7 and 12
  • Case group: children aged between 7 and 12 with a diagnostic of Autism Spectrum Disorders

Exclusion Criteria:

  • Control group: presence of a neurological pathology, mental retardation or language and motor developmental delay
  • Case group: presence of a neurological pathology, mental retardation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108976


Contacts
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Contact: Sandrine SONIE, MD 04 37 91 54 65 ext +33 sandrine.sonie@ch-le-vinatier.fr
Contact: Christina Schmitz, PhD 04 72 13 89 06 ext +33 christina.schmitz@inserm.fr

Locations
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France
CH le Vinatier Recruiting
Bron, France, 69500
Contact: Sandrine SONIE, MD    04 37 91 54 65 ext +33    sandrine.sonie@ch-le-vinatier.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sandrine SONIE, MD CH le Vinatier

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03108976     History of Changes
Other Study ID Numbers: 69HCL16_0677
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Autism
Sensori-motor learning
Development
Neuroimaging

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders