NCT07400484 Differences in N-CAD Concentration and Brain Function Between Children With ASD and TD
| NCT ID | NCT07400484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chen Li |
| Condition | ASD |
| Study Type | OBSERVATIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 98 participants in total. It began in 2025-12-18 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The incidence of autism spectrum disorders is increasing, about 1 / 36. Neural cadherin (NCAD) is closely related to synaptic structure and function. The cdh2 gene encoding NCAD has been shown to be associated with a variety of neurodevelopmental diseases and is one of the six risk genes for ASD. Functional near-infrared spectroscopy (fNIRS) is a neuroimaging technology that uses the principle of near-infrared spectroscopy to detect the functional activation of human cortex. The application of fNIRS to explore the neural mechanism of children with ASD has developed rapidly. It has the advantages of non-invasive, portable, relatively low cost and unlimited physical activity. And for ASD children, their command compliance and self-control are relatively low, so fNIRS is more widely used in ASD children. According to dsm-5 standard, we recruited ASD children and TD children, collected their peripheral blood, and detected the plasma n-cad concentration. At the same time, the resting state of fNIRS of the two groups of children was collected, and the ultra scan monitoring was carried out simultaneously during Gesell assessment. The purpose of this study was to explore the difference of peripheral blood NCAD concentration between preschool ASD children and TD children and the difference of brain function in resting state and social interaction state. And the relationship between the characteristics of brain function and the level of cognitive development in children with ASD.
Eligibility 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.
Contact & Investigator
Li Chen, doctor
STUDY CHAIR
Children's Hospital of Chongqing Medical University
Frequently Asked Questions
Who can join the NCT07400484 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 5 Years, studying ASD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07400484 currently recruiting?
Yes, NCT07400484 is actively recruiting participants. Contact the research team at chenli2012@126.com for enrollment information.
Where is the NCT07400484 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07400484 clinical trial?
NCT07400484 is sponsored by Chen Li. The principal investigator is Li Chen, doctor at Children's Hospital of Chongqing Medical University. The trial plans to enroll 98 participants.