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The Real World Study of Autism Spectrum Disorder in China

The Real World Study of Children With Autism Spectrum Disorder in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04358744
Enrollment
2500
Registered
2020-04-24
Start date
2019-04-13
Completion date
2024-09-30
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief summary

The investigators conduct the real world study to explore mechanisms of autism based on multi-modal data.

Detailed description

Children with autism spectrum disorder registered in Xinhua Hospital are measured in aspects of behavioural accessment, genetic test, blood lab test, gut microbiome and neuroimaging including structural and functional magnetic resonance imaging (MRI), functional near - infrared spectroscopy(f-NIRS), electroencephalography and eye movement. The investigators conduct the real world study to explore mechanisms of autism based on the multi-modal data.

Interventions

None listed

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to 18 Years

Inclusion criteria

* diagnosed with autism spectrum disorder * registered in Xinhua hospital * written informed consent provided

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frameDescription
Behaviour assessmentThe baseline and 3 monthsThe behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.

Other

MeasureTime frameDescription
Blood testThe baseline and 3 monthsRetained blood samples tested in immunomics, metabonomics, etc
Gut mircobiomeThe baseline and 1 monthsRetained stool samples tested in metabonomics, genomics, etc
Head Magnetic Resonance Imaging (Head MRI)The baseline and 3 monthsHead MRI is used to detect the structure and function of the brain.
Genetic characteristicsThe baselineGenome wide association study from blood sample
Multichannel Electroencephalography signalsThe baseline and 3 monthsThe latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions.
Eye movementsThe baseline and 3 monthsVariables measured by eye movements represent cognition.
Behaviour assessmentThe baseline and 6 monthsThe behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc.
Functional near - infrared spectroscopy(f-NIRS)The baseline and 3 monthsHead fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range.

Countries

China

Contacts

Primary ContactFei Li, doctor
feili@shsmu.edu.cn+86-21-25077461

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026