N-CAD levels and resting brain activity in children with autism and typical peers
A Study on the Differences in N-CAD Concentration and Brain Function Between Children With Autism Spectrum Disorder and Typically Developing Children
This will test whether blood N-CAD levels and resting brain activity measured by fNIRS differ between children aged 3–5 with autism and typically developing children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 98 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT07400484 on ClinicalTrials.gov |
What this trial studies
This observational study recruits children aged 3 to under 5 years with autism and age-matched typically developing (TD) children and collects demographic data, neuropsychological assessments, and peripheral blood samples. Plasma N-CAD concentration will be measured from 3 ml blood samples that are rapidly processed and frozen, while resting-state brain activity will be recorded using functional near-infrared spectroscopy (fNIRS), with simultaneous monitoring during Gesell assessment. The planned sample size is about 49 children per group to provide adequate statistical power for group comparisons. Group differences in plasma N-CAD and fNIRS-derived measures will be tested using standard statistical methods.
Who should consider this trial
Good fit: Children aged 3 to under 5 years with a DSM-5/ICD-11 diagnosis of autism confirmed by two qualified clinicians, who have no major medical or sensory impairments and whose caregivers consent to participation, are ideal candidates.
Not a fit: Children with genetic syndromes linked to autism, significant neurological or medical conditions, sensory loss, very low birth weight or preterm birth, or those who are adopted are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If findings show clear differences, this could point to a peripheral biomarker and brain activation patterns that help clarify biological mechanisms in early childhood autism.
How similar studies have performed: fNIRS has been widely used in young children with autism and cdh2/NCAD has been implicated in neurodevelopmental disorders, but combining plasma NCAD measurements with fNIRS in preschool autism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age at enrollment ≥ 3 years and \<5 years; 2. The diagnosis was made by 2 developmental behavioral pediatricians or child psychiatrists with vice senior titles or above, and the history and clinical manifestations were in line with ASD and ICD-11 diagnostic criteria for ASD; . Exclusion Criteria: 1. Diagnosis or manifestation of genetic diseases or syndromes related to ASD (such as Rett syndrome); 2. Medical or nervous system diseases affecting growth, development or cognition (such as central nervous system infection, epilepsy, congenital heart disease, etc.); 3. Sensory impairment such as vision or hearing loss; 4. Low birth weight (birth weight \<2000 g) or preterm birth (gestational age \<37 weeks); 5. Adopted children; 6. Parents refused to sign the informed consent form; 7. Other researchers consider it inappropriate to participate in the study.
Where this trial is running
Chongqing, Chongqing Municipality
- Growth, Development and Mental health of Children and Adolescence Center — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Li Chen, doctor
- Email: chenli2012@126.com
- Phone: 13677620103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.