Characterization of (A)Typical Sensorimotor Pathways in Individuals With Autism (MovAUT)

IRCCS Eugenio Medea

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Diagnostic Test: clinical assessment; Diagnostic Test: Neuropsychological examination; Diagnostic Test: Neurophysiological evaluation; Diagnostic Test: Genetic evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT07389720

95/24 (ex 1105)

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Experimental: Clinical, neuropsychological, neurophysiological, and genetic evaluations

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Neurophysiological evaluation

Diagnostic Test: Neuropsychological examination

Diagnostic Test: clinical assessment

Diagnostic Test: Genetic evaluation