HealthyASD-BARNNCT03108976
Build-up of Action Representation in Autism Spectrum Disorders
A study testing Behavioral assessments, Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) in people with Healthy and Autism Spectrum Disorder, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Autism Spectrum Disorder
- What is being tested?
- Behavioral assessments, Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2015to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Control group: children aged between 7 and 12
- Case group: children aged between 7 and 12 with a diagnostic of Autism Spectrum Disorders
Who cannot join
- Control group: presence of a neurological pathology, mental retardation or language and motor developmental delay
- Case group: presence of a neurological pathology, mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Build-up of Action Representation During Neurodevelopment: Dysfunctions in Autism Spectrum Disorders?
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.
- Conditions
- Healthy, Autism Spectrum Disorder
- Being tested
- Behavioral assessments, Magnetoencephalography (MEG), Magnetic Resonance Imaging (MRI)
- Keywords
- Autism, Sensori-motor learning, Development, Neuroimaging
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral assessmentsOther
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)Other
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)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Children with a typical development. Receives: Other: Behavioral assessments; Other: Magnetoencephalography (MEG); Other: Magnetic Resonance Imaging (MRI) |
| Case group | Active comparator | Children with Autism Spectrum Disorders. Receives: Other: Behavioral assessments; Other: Magnetoencephalography (MEG); Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start10 Apr 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine SONIE, MD, Principal investigator, CH le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108976
- Sponsor's protocol ID
- 69HCL16_0677
- Acronym
- ASD-BARN
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2017
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Build-up of Action Representation During Neurodevelopment: Dysfunctions in Autism Spectrum Disorders?
- ClinicalTrials.gov ID
- NCT03108976
- Acronym / sponsor ID
- ASD-BARN / 69HCL16_0677
- Conditions
- Healthy, Autism Spectrum Disorder
- Keywords
- Autism, Sensori-motor learning, Development, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Behavioral assessments, Other: Magnetoencephalography (MEG), Other: Magnetic Resonance Imaging (MRI)Children with a typical development. |
| Case group | Active comparator | Other: Behavioral assessments, Other: Magnetoencephalography (MEG), Other: Magnetic Resonance Imaging (MRI)Children with Autism Spectrum Disorders. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Control group: children aged between 7 and 12
- Case group: children aged between 7 and 12 with a diagnostic of Autism Spectrum Disorders
Key exclusion criteria (2 listed)
- Control group: presence of a neurological pathology, mental retardation or language and motor developmental delay
- Case group: presence of a neurological pathology, mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral assessmentsKinematics 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 | Case group, Control group |
| 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 | Case group, Control group |
| 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). | Other | Case group, Control group |
Primary outcome
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.
1 secondary outcome
Correlation between oscillatory measures and learning performance.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine SONIE, MD principal investigator
CH le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral assessments, Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) in people with Healthy and Autism Spectrum Disorder, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of cerebral oscillations in three frequency bands (alpha, beta, gamma) during sensori-motor learning. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.