Autism Spectrum DisorderMovAUTNCT07389720
Characterization of (A)Typical Sensorimotor Pathways in Individuals With Autism
A study testing clinical assessment, Neuropsychological examination and Neurophysiological evaluation in people with Autism Spectrum Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The goal of this interventional study is to understand whether sensorimotor skills could represent an endophenotype for autism, i.e. a specific class of biomarkers that bridges the gap between biological components of a condition and the behavioral/clinical dimensions. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- clinical assessment, Neuropsychological examination and Neurophysiological evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- children aged 2 to 12 years (both autistic and typically developing)
- Clinical diagnosis of Autism Spectrum Disorder based on clinical judgment according to DSM-5 criteria (for the autism group).
- being parents of the enrolled children (both autistic and typically developing)
- infants younger than 24 months of age with a first-degree family member with a clinical diagnosis of Autism Spectrum Disorder.
Who cannot join
- Presence of medical and/or neurological conditions of clinical significance, including epilepsy.
- Presence of dysmorphic syndromes or known genetic syndromes.
- Current use of medications and/or psychotropic drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS E. Medea
Bosisio Parini, Lecco, 23842
Alessandro Crippa, PhD, 031877593 ext. +39, alessandro.crippa@lanostrafamiglia.it
About this study
The goal of this interventional study is to understand whether sensorimotor skills could represent an endophenotype for autism, i.e. a specific class of biomarkers that bridges the gap between biological components of a condition and the behavioral/clinical dimensions. Motor and sensory differences are often observed in people with autism and may appear early in development or be shared among family members.
The study will address three main questions:
- What are the developmental effects of early differences in motor and sensory skills?
- Are motor and sensory abilities influenced by family relationships?
- Can studying motor and sensory differences in autism help researchers better understand the biological mechanisms underlying the condition? This study is structured in three topic-oriented work packages (WPs): WP1, a longitudinal assessment of sensorimotor skills as early predictors of later social characteristics in a mixed sample of infant siblings of autistic children (at elevated likelihood of autism) or with typical familial likelihood (no first-degree relatives with autism) (Q1); WP2, a cross-sectional investigation of sensorimotor abilities in autistic children and their parents as compared with typically developing children and their parents (Q2); and WP3, a dense-phenotyping approach to establish, within individuals, associations between traits across behavioral, neural, and molecular levels.
- Conditions
- Autism Spectrum Disorder
- Being tested
- clinical assessment, Neuropsychological examination, Neurophysiological evaluation, Genetic evaluation
- Keywords
- autism, motor skills, social communication, kinematics
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical assessmentDiagnostic test
Clinical evaluation of participants by means of Autism Diagnostic Observation Schedule, Social Responsiveness Scale
Neuropsychological examinationDiagnostic test
The participants' motor skills are measured using the Movement Assessment Battery for Children 3 (MABC3), the Developmental Coordination Disorder Questionnaire (DCDQ) or the Adult Developmental Coordination Disorder/Dyspraxia Checklist (ADC), and the kinematic analysis of upper-limb movements during two experimental tasks: (a) a reaching-and-inserting task involving a ball (ball task), and (b) a task requiring grasping a moving ball (ball-rolling task).
Neurophysiological evaluationDiagnostic test
Magnetic Resonance Imaging (structural MRI and spectroscopy)
Genetic evaluationDiagnostic test
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. Variant Call Format 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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations | Experimental | All children and their parents enrolled in the study will undergo an assessment of intellectual functioning, and a direct evaluation of motor skills using the Movement Assessment Battery for Children - Thirs Edition (MABC-3). Motor skills will also be assessed indirectly through either a parent or self-completed questionnaire. The motor profile of the participants will be further characterized using kinematic analysis of upper-limb movements during two experimental tasks. Receives: Diagnostic Test: clinical assessment; Diagnostic Test: Neuropsychological examination; Diagnostic Test: Neurophysiological evaluation; Diagnostic Test: Genetic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Assessment Battery for Children 3 (MABC3)
The Movement ABC-3 (Movement Assessment Battery for Children, Third Edition) is a comprehensive, standardized assessment tool for identifying gross and fine motor coordination difficulties in individuals aged 3 to 25, assessing skills like dexterity, aiming, catching, balance, and locomotion.
Measured: immediately after the intervention
Developmental Coordination Disorder Questionnaire (DCDQ)
The Developmental Coordination Disorder Questionnaire (DCDQ) 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.
Measured: immediately after the intervention
Adult Developmental Coordination Disorder/Dyspraxia Checklist (ADC)
The Adult Developmental Coordination Disorder/Dyspraxia Checklist (ADC) is a self-report screening tool for adults (16+) to identify potential Developmental Coordination Disorder (DCD/Dyspraxia) by assessing lifelong motor challenges in daily activities
Measured: immediately after the intervention
kinematic analysis of two motor tasks
(a) a reaching-and-inserting task involving a ball (ball task), which consists in reaching and grasping a rubber ball (diameter: 6 cm) placed over a support and dropping it in a small basket, provided with a hole large enough (diameter: 7 cm) not to require fine movements; (b) a task requiring grasping a moving ball (ball-rolling task) which requires participants to catch a ball rolling toward them on a curvilinear path off an inclined tabletop. As outcome measure, we will consider the total movement duration (recorded in sec).
Measured: immediately after the intervention
Secondary outcomes (3)
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)
Measured: immediately after the intervention
Magnetic Resonance Spectroscopy
Magnetic Resonance Spectroscopy (MRS) is a non-invasive technique, often used with MRI, that measures the chemical makeup (metabolites) of tissues like the brain.
Measured: immediately after the intervention
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. Variant Call Format file will be then marked using wANNOVAR (Wang Genomics Lab).
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start21 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389720
- Sponsor's protocol ID
- 95/24 (ex 1105)
- Acronym
- MovAUT
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of (A)Typical Sensorimotor Pathways in Individuals With Autism
- ClinicalTrials.gov ID
- NCT07389720
- Acronym / sponsor ID
- MovAUT / 95/24 (ex 1105)
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, motor skills, social communication, kinematics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (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.
The goal of this interventional study is to understand whether sensorimotor skills could represent an endophenotype for autism, i.e. a specific class of biomarkers that bridges the gap between biological components of a condition and the behavioral/clinical dimensions. Motor and sensory differences are often observed in people with autism and may appear early in development or be shared among family members.
The study will address three main questions:
- What are the developmental effects of early differences in motor and sensory skills?
- Are motor and sensory abilities influenced by family relationships?
- Can studying motor and sensory differences in autism help researchers better understand the biological mechanisms underlying the condition? This study is structured in three topic-oriented work packages (WPs): WP1, a longitudinal assessment of sensorimotor skills as early predictors of later social characteristics in a mixed sample of infant siblings of autistic children (at elevated likelihood of autism) or with typical familial likelihood (no first-degree relatives with autism) (Q1); WP2, a cross-sectional investigation of sensorimotor abilities in autistic children and their parents as compared with typically developing children and their parents (Q2); and WP3, a dense-phenotyping approach to establish, within individuals, associations between traits across behavioral, neural, and molecular levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations | Experimental | Diagnostic Test: clinical assessment, Diagnostic Test: Neuropsychological examination, Diagnostic Test: Neurophysiological evaluation, Diagnostic Test: Genetic evaluationAll children and their parents enrolled in the study will undergo an assessment of intellectual functioning, and a direct evaluation of motor skills using the Movement Assessment Battery for Children - Thirs Edition (MABC-3). Motor skills will also be assessed indirectly through either a parent or self-completed questionnaire. The motor profile of the participants will be further characterized using kinematic analysis of upper-limb movements during two experimental tasks. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- children aged 2 to 12 years (both autistic and typically developing)
- Clinical diagnosis of Autism Spectrum Disorder based on clinical judgment according to DSM-5 criteria (for the autism group).
- being parents of the enrolled children (both autistic and typically developing)
- infants younger than 24 months of age with a first-degree family member with a clinical diagnosis of Autism Spectrum Disorder.
Key exclusion criteria (3 listed)
- Presence of medical and/or neurological conditions of clinical significance, including epilepsy.
- Presence of dysmorphic syndromes or known genetic syndromes.
- Current use of medications and/or psychotropic drugs.
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 |
|---|---|---|
| clinical assessmentClinical evaluation of participants by means of Autism Diagnostic Observation Schedule, Social Responsiveness Scale | Diagnostic test | Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations |
| Neuropsychological examinationThe participants' motor skills are measured using the Movement Assessment Battery for Children 3 (MABC3), the Developmental Coordination Disorder Questionnaire (DCDQ) or the Adult Developmental Coordination Disorder/Dyspraxia Checklist (ADC), and the kinematic analysis of upper-limb movements during two experimental tasks: (a) a reaching-and-inserting task involving a ball (ball task), and (b) a task requiring grasping a moving ball (ball-rolling task). | Diagnostic test | Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations |
| Neurophysiological evaluationMagnetic Resonance Imaging (structural MRI and spectroscopy) | Diagnostic test | Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations |
| Genetic evaluationEither 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. Variant Call Format 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 | Diagnostic test | Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations |
Primary outcome
Movement Assessment Battery for Children 3 (MABC3)
Time frame: immediately after the intervention
The Movement ABC-3 (Movement Assessment Battery for Children, Third Edition) is a comprehensive, standardized assessment tool for identifying gross and fine motor coordination difficulties in individuals aged 3 to 25, assessing skills like dexterity, aiming, catching, balance, and locomotion.
Developmental Coordination Disorder Questionnaire (DCDQ)
Time frame: immediately after the intervention
The Developmental Coordination Disorder Questionnaire (DCDQ) 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.
Adult Developmental Coordination Disorder/Dyspraxia Checklist (ADC)
Time frame: immediately after the intervention
The Adult Developmental Coordination Disorder/Dyspraxia Checklist (ADC) is a self-report screening tool for adults (16+) to identify potential Developmental Coordination Disorder (DCD/Dyspraxia) by assessing lifelong motor challenges in daily activities
kinematic analysis of two motor tasks
Time frame: immediately after the intervention
(a) a reaching-and-inserting task involving a ball (ball task), which consists in reaching and grasping a rubber ball (diameter: 6 cm) placed over a support and dropping it in a small basket, provided with a hole large enough (diameter: 7 cm) not to require fine movements; (b) a task requiring grasping a moving ball (ball-rolling task) which requires participants to catch a ball rolling toward them on a curvilinear path off an inclined tabletop. As outcome measure, we will consider the total movement duration (recorded in sec).
3 secondary outcomes
Magnetic Resonance (MRI)
Time frame: immediately after the intervention
Magnetic Resonance Spectroscopy
Time frame: immediately after the intervention
Exome sequencing
Time frame: immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical assessment, Neuropsychological examination and Neurophysiological evaluation in people with Autism Spectrum Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. 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 Italy. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Crippa, PhD (39 031877593, alessandro.crippa@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Assessment Battery for Children 3 (MABC3) (time frame: immediately after the intervention). The study lists 4 primary outcomes in all. 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 5 Feb 2026.