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Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach (MOSAICO)

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ClinicalTrials.gov Identifier: NCT04769011
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
IRCCS Eugenio Medea

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Intellectual Disability Diagnostic Test: Clinical evaluation Diagnostic Test: Neuropsychological evaluation Diagnostic Test: Neurophysiological evaluation Diagnostic Test: Genetic evaluation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations
Clinical, neuropsychological, neurophysiological, and genetic evaluations
Diagnostic Test: Clinical evaluation
Clinical evaluation of participants by means of Autism Diagnostic Observation Schedule, Social Responsiveness Scale, Children Behavior Check List, Conners' Scale

Diagnostic Test: Neuropsychological evaluation
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).

Diagnostic Test: Neurophysiological evaluation
Magnetic Resonance Imaging (structural MRI and DTI)

Diagnostic Test: Genetic evaluation
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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

  6. 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).



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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04769011


Contacts
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Contact: Alessandro Crippa, PhD 031877593 ext +39 alessandro.crippa@lanostrafamiglia.it

Locations
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Italy
IRCCS E. Medea Recruiting
Bosisio Parini, Lecco, Italy, 23842
Contact: Alessandro Crippa, PhD    031877593 ext +39    alessandro.crippa@lanostrafamiglia.it   
Sponsors and Collaborators
IRCCS Eugenio Medea
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Responsible Party: IRCCS Eugenio Medea
ClinicalTrials.gov Identifier: NCT04769011    
Other Study ID Numbers: 510
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intellectual Disability
Disease
Autistic Disorder
Attention Deficit Disorder with Hyperactivity
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurologic Manifestations
Nervous System Diseases
Neurobehavioral Manifestations