- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04769011
Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach (MOSAICO)
March 27, 2024 updated by: IRCCS Eugenio Medea
The general goal of the present proposal, Progetto MOSAICO, is the identification of a multimodal panel of neuropsychological, kinematic, neurophysiological, and genetic markers associated with motor abnormalities present in ASD.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lecco
-
Bosisio Parini, Lecco, Italy, 23842
- IRCCS E. Medea
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 14 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- having a clinical diagnosis of neurodevelopmental disorders (either ASD, ADHD, or intellectual disability) according to DSM-5 criteria;
- children with typical development are also recruited from the general population by local pediatricians or from kindergartens/schools sited near our institute
Exclusion Criteria:
- using any stimulant or non-stimulant medication affecting the central nervous system
- having an identified genetic disorder
- having vision or hearing problems
- suffering from chronic or acute medical illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations
|
Clinical evaluation of participants by means of Autism Diagnostic Observation Schedule, Social Responsiveness Scale, Children Behavior Check List, Conners' Scale
The participants' motor skills are measured using the Movement Assessment Battery for Children 2 (MABC2) (Henderson et al., 2007), the Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007), and the kinematic analysis of a reach-to-drop task (Forti et al., 2011; Crippa et al., 2015).Sensorimotor domain will be also further investigated with NEPSY-II (Korkman et al., 2007) (Fingertip Tapping, Imitating Hand Positions, Manual Motor Sequences, and Visuomotor Precision).
Magnetic Resonance Imaging (structural MRI and DTI)
Either blood or saliva will be obtained for participants for DNA collection.
DNA will be extracted in the Molecular Biology Laboratory at the Scientific Institute IRCCS Medea.
Captured exome libraries will be sequenced using the Illumina NextSeq 500 in 100 bp paired end reads.
Postsequencing reads will be aligned using BWA Enrichment application on BaseSpace.
VCF file will be then marked using wANNOVAR (Wang Genomics Lab).
The analysis will be focused on non-synonymous variants enrichment in Gene Ontology and Human Phenotype.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Movement Assessment Battery for Children 2 (MABC2)
Time Frame: immediately after the intervention
|
The MABC2 (Henderson et al., 2007) is one of the most commonly used tests for the identification of motor difficulties in children aged 3-16 years.
The MABC2 includes eight subtests grouped into three areas related to different components of motor domain: manual dexterity, ball skills (such as aiming and catching), and static and dynamic balance.
|
immediately after the intervention
|
Developmental Coordination Disorder Questionnaire (DCDQ)
Time Frame: immediately after the intervention
|
The DCDQ (Wilson et al., 2007) is a parent questionnaire originally developed for estimating gross and fine motor skill difficulties in children.
The questionnaire consists of 15 items investigating different subdomains of motor abilities, such as ball skills, complex motor coordination, fine and general motor skills.
For each item, parents rate the children's degree of motor coordination on a 5-point scale comparing it to same-age peers.
|
immediately after the intervention
|
kinematic analysis of a reach-to-drop task
Time Frame: immediately after the intervention
|
3D kinematic data of a reach-to-drop movement are collected by a motion-capture system (The SMART D from BTS Bioengineering® - Garbagnate Milanese, Italy).
The reach-to-drop task consists in reaching and grasping a ball placed over a support and dropping it in a hole (Fig. 1; Forti et al., 2011; Crippa et al., 2015).
The task is simple enough to warrant compliance by all children across groups.
Each participant is asked to complete at least five trials of the task with their dominant hand.
Kinematic data are recorded by eight infrared-motion analysis cameras at 60 Hz with a spatial accuracy of 0.2 mm.
|
immediately after the intervention
|
Magnetic Resonance (MRI)
Time Frame: immediately after the intervention
|
Magnetic Resonance (MRI) of the Brain - MRI signal allowing tridimensional multiplanar reconstruction of the brain's structures.
Anatomical images obtained with high definition T1 weighted sequences of radio frequencies - the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)
|
immediately after the intervention
|
Diffusion Tensor Imaging (DTI)
Time Frame: immediately after the intervention
|
Diffusion Tensor Imaging (DTI) measures of the brain microstructure and connectivity - as in all MRI techniques, the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel
|
immediately after the intervention
|
Exome sequencing
Time Frame: immediately after the intervention
|
Exome libraries will be sequenced using the Illumina NextSeq 500 in 100 bp paired end reads.
Postsequencing reads will be aligned using BWA Enrichment application on BaseSpace.
VCF file will be then marked using wANNOVAR (Wang Genomics Lab).
|
immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2018
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
February 11, 2021
First Submitted That Met QC Criteria
February 23, 2021
First Posted (Actual)
February 24, 2021
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 27, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Autistic Disorder
- Autism Spectrum Disorder
- Child Development Disorders, Pervasive
- Intellectual Disability
Other Study ID Numbers
- 510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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