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

Primary Purpose

Healthy, Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Behavioral assessments
Magnetoencephalography (MEG)
Magnetic Resonance Imaging (MRI)
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Autism, Sensori-motor learning, Development, Neuroimaging

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CH le Vinatier

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Control group

Case group

Arm Description

Children with a typical development.

Children with Autism Spectrum Disorders.

Outcomes

Primary Outcome Measures

Changes of cerebral oscillations in three frequency bands (alpha, beta, gamma) during sensori-motor learning.
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

Correlation between oscillatory measures and learning performance.
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.

Full Information

First Posted
March 30, 2017
Last Updated
August 25, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03108976
Brief Title
Build-up of Action Representation in Autism Spectrum Disorders
Acronym
ASD-BARN
Official Title
Build-up of Action Representation During Neurodevelopment: Dysfunctions in Autism Spectrum Disorders?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Autism Spectrum Disorder
Keywords
Autism, Sensori-motor learning, Development, Neuroimaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Children with a typical development.
Arm Title
Case group
Arm Type
Active Comparator
Arm Description
Children with Autism Spectrum Disorders.
Intervention Type
Other
Intervention Name(s)
Behavioral assessments
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Magnetoencephalography (MEG)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
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 Measure Information:
Title
Changes of cerebral oscillations in three frequency bands (alpha, beta, gamma) during sensori-motor learning.
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Correlation between oscillatory measures and learning performance.
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandrine SONIE, MD
Organizational Affiliation
CH le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH le Vinatier
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

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Build-up of Action Representation in Autism Spectrum Disorders

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