Actively Recruiting

Age: 3Years - 5Years
All Genders
Healthy Volunteers
ID07400484

Differences in N-CAD Concentration and Brain Function Between Children With Autism Spectrum Disorder and Typically Developing Children

Led by Chen Li · Updated on 2026-02-10

98

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are examining differences in neural cadherin (NCAD) levels and brain function between preschool children with autism spectrum disorder (ASD) and typically developing (TD) children. The study focuses on NCAD, a protein related to synaptic function, and uses functional near-infrared spectroscopy (fNIRS) to explore brain activity in resting and social interaction states. The goal is to understand how brain function characteristics relate to cognitive development in children with ASD. Children aged 3 to under 5 years with ASD or typical development are enrolled. Blood samples are collected to measure plasma NCAD concentration, and brain activity is recorded using fNIRS while children are at rest and during the Gesell developmental assessment. The TD group is matched to the ASD group by age and gender, ensuring normal developmental levels. Participants undergo physical measurements, blood and nutrient tests, neuropsychological assessments, and fNIRS imaging. Caregivers complete demographic questionnaires, and clinical data are verified from medical records. The study measures NCAD levels and brain function at baseline, analyzing data for correlations with developmental quotients. Ethical approval and informed consent are secured, with privacy protections in place. The study aims to include 49 children in each group and monitors data quality and safety throughout.

CONDITIONS

Brief Title

Differences in N-CAD Concentration and Brain Function Between Children With ASD and TD

Who Can Participate

Age: 3Years - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at enrollment 3 years and under 5 years
  • Diagnosis of autism spectrum disorder confirmed by two developmental behavioral pediatricians or child psychiatrists with appropriate qualifications
  • Diagnosis and clinical history meet ASD and ICD-11 criteria
  • Typically developing children matched by age and gender with normal developmental levels (Gesell DQ 85 or higher)
Not Eligible

You will not qualify if you...

  • Diagnosis or signs of genetic diseases or syndromes related to ASD, such as Rett syndrome
  • Medical or nervous system diseases affecting growth, development, or cognition (e.g., central nervous system infection, epilepsy, congenital heart disease)
  • Sensory impairments such as vision or hearing loss
  • Low birth weight (under 2000 grams) or preterm birth (before 37 weeks gestation)
  • Adopted children
  • Parents refuse to sign informed consent
  • Considered inappropriate to participate by other researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants complete physical measurements, blood tests, neuropsychological assessments, and near-infrared brain functional imaging.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion (approximately 3 years)

Collected data including blood samples and brain imaging are analyzed to compare children with ASD and typically developing children.

No additional visits required

Trial Site Locations

Total: 1 location

1

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, China, 400014

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Research Team

L

Li Chen, doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years--Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2012.

Deborah L Christensen, Jon Baio, Kim Van Naarden Braun...

https://pubmed.ncbi.nlm.nih.gov/27031587