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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04358744
Other study ID # XH-20-005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 13, 2019
Est. completion date September 2024

Study information

Verified date April 2021
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact Fei Li, doctor
Phone +86-21-25077461
Email feili@shsmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers
Gender All
Age group 18 Months to 18 Years
Eligibility Inclusion Criteria: - diagnosed with autism spectrum disorder - registered in Xinhua hospital - written informed consent provided Exclusion Criteria: - NA

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China ShanghaiXinhua Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Genetic characteristics Genome wide association study from blood sample The baseline
Other Blood test Retained blood samples tested in immunomics, metabonomics, etc The baseline and 3 months
Other Blood test Retained blood samples tested in immunomics, metabonomics, etc The baseline and 6 months
Other Blood test Retained blood samples tested in immunomics, metabonomics, etc The baseline and 12 months
Other Gut mircobiome Retained stool samples tested in metabonomics, genomics, etc The baseline and 1 months
Other Gut mircobiome Retained stool samples tested in metabonomics, genomics, etc The baseline and 3 months
Other Gut mircobiome Retained stool samples tested in metabonomics, genomics, etc The baseline and 6 months
Other Gut mircobiome Retained stool samples tested in metabonomics, genomics, etc The baseline and 12 months
Other Head Magnetic Resonance Imaging (Head MRI) Head MRI is used to detect the structure and function of the brain. The baseline and 3 months
Other Head Magnetic Resonance Imaging (Head MRI) Head MRI is used to detect the structure and function of the brain. The baseline and 12 months
Other Functional near - infrared spectroscopy(f-NIRS) Head 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. The baseline and 3 months
Other Functional near - infrared spectroscopy(f-NIRS) Head 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. The baseline and 6 months
Other Functional near - infrared spectroscopy(f-NIRS) Head 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. The baseline and 12 months
Other Multichannel Electroencephalography signals The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions. The baseline and 3 months
Other Multichannel Electroencephalography signals The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions. The baseline and 6 months
Other Multichannel Electroencephalography signals The latency and amplitude measured by electroencephalogram can reflect the connectivity between brain regions. The baseline and 12 months
Other Eye movements Variables measured by eye movements represent cognition. The baseline and 3 months
Other Eye movements Variables measured by eye movements represent cognition. The baseline and 6 months
Other Eye movements Variables measured by eye movements represent cognition. The baseline and 12 months
Other Behaviour assessment The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc. The baseline and 6 months
Other Behaviour assessment The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc. The baseline and 12 months
Primary Behaviour assessment The behaviour development of participants includes intellectual/developmental quotient, syptoms severity, comorbidity, etc. The baseline and 3 months
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