Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach - Clinical Trial for Autism Spectrum Disorder | NCT04769011

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Clinical evaluation

Neuropsychological evaluation

Neurophysiological evaluation

Genetic evaluation

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder

Eligibility Criteria

1 Year - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

IRCCS E. MedeaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clinical, neuropsychological, neurophysiological, and genetic evaluations

Arm Description

Clinical, neuropsychological, neurophysiological, and genetic evaluations

Outcomes

Primary Outcome Measures

Movement Assessment Battery for Children 2 (MABC2)

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.

Developmental Coordination Disorder Questionnaire (DCDQ)

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.

kinematic analysis of a reach-to-drop task

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.

Magnetic Resonance (MRI)

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)

Diffusion Tensor Imaging (DTI)

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

Exome sequencing

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT04769011

First Posted

February 11, 2021

Last Updated

March 17, 2023

Sponsor

IRCCS Eugenio Medea

1. Study Identification

Unique Protocol Identification Number

NCT04769011

Brief Title

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

Acronym

MOSAICO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 2, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IRCCS Eugenio Medea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Intellectual Disability

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Clinical, neuropsychological, neurophysiological, and genetic evaluations

Arm Type

Experimental

Arm Description

Clinical, neuropsychological, neurophysiological, and genetic evaluations

Intervention Type

Diagnostic Test

Intervention Name(s)

Clinical evaluation

Intervention Description

Clinical evaluation of participants by means of Autism Diagnostic Observation Schedule, Social Responsiveness Scale, Children Behavior Check List, Conners' Scale

Intervention Type

Diagnostic Test

Intervention Name(s)

Neuropsychological evaluation

Intervention Description

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).

Intervention Type

Diagnostic Test

Intervention Name(s)

Neurophysiological evaluation

Intervention Description

Magnetic Resonance Imaging (structural MRI and DTI)

Intervention Type

Diagnostic Test

Intervention Name(s)

Genetic evaluation

Intervention Description

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 Measure Information:

Title

Movement Assessment Battery for Children 2 (MABC2)

Description

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.

Time Frame