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RecruitingNCT07064967Updated Jul 15, 2025

Non-Helium Magnetoencephalography in Autism Spectrum Disorder

An observational study in Autism Spectrum Disorder (ASD), sponsored by Guangzhou Women and Children's Medical Center. Recruiting at 1 site in China. Open to male participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by Guangzhou Women and Children's Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
6 Years to 12 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Autism Spectrum Disorder (ASD)

Keywords

  • Autism Spectrum Disorder
  • Magnetoencephalography
03

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pediatric patients of Guangzhou Women and Children's Medical Center

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testMagnetoencephalography

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

05

What researchers measure

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.

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

06

Study locations

1 of 1 sites recruiting
  • Guangzhou Women and Children's medical center
    Guangzhou, Guangdong 511399, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07064967
Lead sponsor
Guangzhou Women and Children's Medical Center
Collaborators
Beijing X-Magtech Technology Limited
Responsible party
Sponsor
First posted
Jul 15, 2025
Start date
Nov 5, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 15, 2025

Study contacts

Ye Song, Medical Doctor
Contact
15625984282@163.com
+86-020-81886332

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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