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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03108976
Other study ID # 69HCL16_0677
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2015
Est. completion date December 31, 2018

Study information

Verified date August 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).
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).
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).

Locations

Country Name City State
France CH le Vinatier Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day 1
Secondary 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. Day 1
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