NCT03108976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

3.7 years

First QC Date

March 30, 2017

Last Update Submit

August 25, 2022

Conditions

Keywords

AutismSensori-motor learningDevelopmentNeuroimaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation between oscillatory measures and learning performance.

    Day 1

Study Arms (2)

Control group

SHAM COMPARATOR

Children with a typical development.

Other: Behavioral assessmentsOther: Magnetoencephalography (MEG)Other: Magnetic Resonance Imaging (MRI)

Case group

ACTIVE COMPARATOR

Children with Autism Spectrum Disorders.

Other: Behavioral assessmentsOther: Magnetoencephalography (MEG)Other: Magnetic Resonance Imaging (MRI)

Interventions

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).

Case groupControl group

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).

Case groupControl group

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).

Case groupControl group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH le Vinatier

Bron, 69500, France

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Interventions

MagnetoencephalographyMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Officials

  • Sandrine SONIE, MD

    CH le Vinatier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 11, 2017

Study Start

April 10, 2015

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 26, 2022

Record last verified: 2022-08

Locations