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

February 2, 2026 updated by: Chen Li

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

  1. Procedure. Children in ASD group and TD group will complete free physical measurement, blood routine and serum nutrient tests, neuropsychological assessment, and near-infrared brain functional imaging after signing up and giving informed consent. 3ml of peripheral blood was collected from the subjects, and the plasma was rapidly separated and frozen in a -80 ℃ refrigerator. The resting state of ASD and TD children was collected using fNIRS, and the ultra scan monitoring was performed simultaneously during Gesell assessment
  2. Demographic questionnaires and clinical data. The demographic questionnaire was completed by the child's primary caregiver, specifying the child's name, sex, and date of birth. Clinical data will be determined from medical records, including relevant dsm-5 diagnosis, disease classification, etc. The
  3. Sample size. The sample size was calculated by g*power 3.1. The paired t-test was used to set the effect size d=0.35, α =0.05 (two-sided) Power=0.9， Software calculation showed that 44 cases were needed in each group. Considering the group variability of children and the 10% dropout rate, 49 cases in each group (49 cases in ASD group and 49 cases in TD group) were finally included.
  4. Statistical analysis. ① NCAD: the R language 4.5.1 statistical software is used for data analysis. The measurement data conforming to the normal distribution adopts the mean ± standard deviation, and the paired sample t test is used for comparison between groups; The median (quartile) was used for non normally distributed measurement data, and Wilcoxon signed rank test was used for comparison between groups. ② Near infrared: nirspark software was used for data preprocessing, R language 4.5.1 statistical software was used for data analysis, Pearson correlation was used for correlation between channels, and generalized linear model (GLM) or mixed effects model was used for comparison between groups. Multiple linear regression model (adjusting for covariates such as age and gender) was used to explore the association between brain activation and DQ level in children with ASD.
  5. ethical issues and data protection. Patients participating in the study will sign an informed consent form. This study was approved by the local ethics committee. . Parents' authorization of patients' health information remained valid until the study was completed. After that, the researcher will delete the private information from the research record.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400014
        • Recruiting
        • Growth, Development and Mental health of Children and Adolescence Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

ASD

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
N-CAD
Time Frame: Baseline
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chen Li

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Li Chen, doctor, Children's Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DNCBFBCASDTDC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is confidential during the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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