Autism Spectrum Disorder (ASD)NCT07064967
Non-Helium Magnetoencephalography in Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder (ASD), run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Magnetoencephalography
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- Men only
- Healthy volunteers accepted
- Child
Study population: Pediatric patients of Guangzhou Women and Children's Medical Center
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's medical center
Guangzhou, Guangdong, 511399
Wenhao Zhou, Medical Doctor, +86-020-81886332, 15625984282@163.com
About this study
Official title: Non-Helium Magnetoencephalography for Identifying Neurobiological Features and Functional Biomarkers in Children With Autism Spectrum Disorder: An Observational Cohort Study
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.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Magnetoencephalography
- Keywords
- Autism Spectrum Disorder, Magnetoencephalography
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetoencephalographyDiagnostic test
Participants will undergo magnetoencephalography scan in both resting and tasking state.
| Study group | Role | What they receive |
|---|---|---|
| ASD | Participants in the ASD group consisted of children diagnosed with Autism Spectrum Disorder according to DSM-5 criteria. Receives: Diagnostic Test: Magnetoencephalography | |
| Control | Participants in the Control group consisted of typically developing children. Receives: Diagnostic Test: Magnetoencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment (single time point, within 1 week of enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start5 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing X-Magtech Technology Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064967
- Sponsor's protocol ID
- 447A01
- Status last verified
- Nov 2024
- First submitted
- 3 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Helium Magnetoencephalography for Identifying Neurobiological Features and Functional Biomarkers in Children With Autism Spectrum Disorder: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07064967
- Acronym / sponsor ID
- 447A01
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- Autism Spectrum Disorder, Magnetoencephalography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Collaborators
- Beijing X-Magtech Technology Limited
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD | – | Diagnostic Test: MagnetoencephalographyParticipants in the ASD group consisted of children diagnosed with Autism Spectrum Disorder according to DSM-5 criteria. |
| Control | – | Diagnostic Test: MagnetoencephalographyParticipants in the Control group consisted of typically developing children. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients of Guangzhou Women and Children's Medical Center
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnetoencephalographyParticipants will undergo magnetoencephalography scan in both resting and tasking state. | Diagnostic test | ASD, Control |
Primary outcome
Identification of Neural Oscillation Characteristics in Children with Autism Spectrum Disorder
Time frame: Baseline assessment (single time point, within 1 week of enrollment).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder (ASD), run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ye Song, Medical Doctor (+86-020-81886332, 15625984282@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Neural Oscillation Characteristics in Children with Autism Spectrum Disorder (time frame: Baseline assessment (single time point, within 1 week of enrollment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.