NCT07064967

Brief Summary

The goal of this observational study is to learn how brain activity in children with autism spectrum disorder (ASD) differs from typical developing children using magnetoencephalography (MEG). The main questions this study aims to answer are: Do children with ASD show different patterns of neural oscillation compared to typically developing children? Can MEG identify specific brain features that help ASD diagnosis? Participants will undergo MEG scan in both resting and tasking state, and their brain activity will be analyzed for characteristic neural oscillations and connectivity patterns. This study may help develop better tools for early ASD diagnosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Nov 2024

Typical duration 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

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Study Timeline

Key milestones and dates

Study Progress48%
Nov 2024Dec 2027

Study Start

First participant enrolled

November 5, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 15, 2025

Status Verified

November 1, 2024

Enrollment Period

3.2 years

First QC Date

July 3, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

Autism Spectrum DisorderMagnetoencephalography

Outcome Measures

Primary Outcomes (1)

  • Identification of Neural Oscillation Characteristics in Children with Autism Spectrum Disorder

    The primary outcome will measure group differences in neural oscillation features (e.g., spectral power and spatial distribution) across frequency bands (alpha, beta, gamma) between children with Autism Spectrum Disorder and typically developing children during resting-state and task-based conditions. Quantified using time-frequency analysis of magnetoencephalography data. Statistical analysis will include independent t-tests (or Mann-Whitney U tests for non-normally distributed data) with false discovery rate (FDR) correction, using SPSS version 27.0.

    Baseline assessment (single time point, within 1 week of enrollment).

Study Arms (2)

ASD

Participants in the ASD group consisted of children diagnosed with Autism Spectrum Disorder according to DSM-5 criteria.

Diagnostic Test: Magnetoencephalography

Control

Participants in the Control group consisted of typically developing children.

Diagnostic Test: Magnetoencephalography

Interventions

MagnetoencephalographyDIAGNOSTIC_TEST

Participants will undergo magnetoencephalography scan in both resting and tasking state.

ASDControl

Eligibility Criteria

Age6 Years - 12 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients of Guangzhou Women and Children's Medical Center

You may qualify if:

  • Boys aged 6 to 12 years;
  • Diagnosis of Autism Spectrum Disorder meeting DSM-5 criteria;
  • Intelligence quotient (IQ) score \> 70 (assessed via Wechsler Intelligence Scale for Children or other validated cognitive test);
  • Sufficient compliance to participate in MEG experiments.

You may not qualify if:

  • Comorbid neurological disorders, genetic syndromes, or severe developmental disabilities;
  • Metallic implants that may interfere with MEG signal acquisition;
  • Current use of antipsychotic medications or sedatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's medical center

Guangzhou, Guangdong, 511399, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Magnetoencephalography

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative Techniques

Central Study Contacts

Ye Song, Medical Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 15, 2025

Study Start

November 5, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 15, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations