NCT07400484

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 25, 2026

Last Update Submit

February 2, 2026

Conditions

Keywords

ASDNeural cadherinFunctional Near-infrared Spectroscopy

Outcome Measures

Primary Outcomes (2)

  • N-CAD

    NCAD concentration in peripheral blood: N-cadherin (NCAD) in peripheral blood is a calcium dependent cell adhesion molecule, which is mainly involved in cell-cell recognition and adhesion, and is commonly found in nerve tissue, muscle and vascular endothelium. In peripheral blood, the content is very low under normal conditions, but if N-cadherin is detected to be increased, it may be related to tumor metastasis (such as breast cancer, prostate cancer and other epithelial mesenchymal transition), vascular endothelial injury or some neurological diseases. It can be used as a potential biological marker of tumor invasion or vascular abnormalities, but its detection needs to be combined with other indicators to improve the accuracy.

    Baseline

  • fNIRS

    FNIRS (resting state + superscan): functional near infrared spectroscopy (fNIRS) is a noninvasive brain imaging method that detects hemodynamic changes in the cerebral cortex (such as oxygenated hemoglobin and deoxyhemoglobin concentrations) through near-infrared light, thereby indirectly reflecting neural activity. Resting state fNIRS is used to study the spontaneous activity of the brain in the task-free state, and is often used to explore brain functional networks, disease markers (such as mental disorders or neurodegenerative diseases) and individual differences. While fNIRS hyperscanning synchronously records the brain activity of multiple subjects (such as two people interacting), which is used to study the inter brain synchronization in social cognition, cooperation or competition, and reveal the interpersonal neural mechanism. The combination of the two can expand the understanding of brain resting function and social interaction, and is suitable for psychology, neuroscience a

    Baseline

Study Arms (2)

ASD

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.

TD

Match children with ASD based on age and gender, with normal developmental levels (Gesell DQ ≥ 85).

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

ASD

You may qualify if:

  • Age at enrollment ≥ 3 years and \<5 years;
  • 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; .

You may not qualify if:

  • Diagnosis or manifestation of genetic diseases or syndromes related to ASD (such as Rett syndrome);
  • Medical or nervous system diseases affecting growth, development or cognition (such as central nervous system infection, epilepsy, congenital heart disease, etc.);
  • Sensory impairment such as vision or hearing loss;
  • Low birth weight (birth weight \<2000 g) or preterm birth (gestational age \<37 weeks);
  • Adopted children;
  • Parents refused to sign the informed consent form;
  • Other researchers consider it inappropriate to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (5)

  • Harrison OJ, Jin X, Hong S, Bahna F, Ahlsen G, Brasch J, Wu Y, Vendome J, Felsovalyi K, Hampton CM, Troyanovsky RB, Ben-Shaul A, Frank J, Troyanovsky SM, Shapiro L, Honig B. The extracellular architecture of adherens junctions revealed by crystal structures of type I cadherins. Structure. 2011 Feb 9;19(2):244-56. doi: 10.1016/j.str.2010.11.016.

  • Jobsis FF. Noninvasive, infrared monitoring of cerebral and myocardial oxygen sufficiency and circulatory parameters. Science. 1977 Dec 23;198(4323):1264-7. doi: 10.1126/science.929199.

  • Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.

  • Liu D, Cao H, Kural KC, Fang Q, Zhang F. Integrative analysis of shared genetic pathogenesis by autism spectrum disorder and obsessive-compulsive disorder. Biosci Rep. 2019 Dec 20;39(12):BSR20191942. doi: 10.1042/BSR20191942.

  • Christensen DL, Baio J, Van Naarden Braun K, Bilder D, Charles J, Constantino JN, Daniels J, Durkin MS, Fitzgerald RT, Kurzius-Spencer M, Lee LC, Pettygrove S, Robinson C, Schulz E, Wells C, Wingate MS, Zahorodny W, Yeargin-Allsopp M; Centers for Disease Control and Prevention (CDC). Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years--Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2012. MMWR Surveill Summ. 2016 Apr 1;65(3):1-23. doi: 10.15585/mmwr.ss6503a1.

Biospecimen

Retention: SAMPLES WITH DNA

3ml of peripheral blood was collected from the subjects, and the plasma was rapidly separated and frozen in a -80 ℃ refrigerator.

Study Officials

  • Li Chen, doctor

    Children's Hospital of Chongqing Medical University

    STUDY CHAIR

Central Study Contacts

Li Chen, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor,Director

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 10, 2026

Study Start

December 18, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Data is confidential during the study.

Locations