Autism Spectrum Disorder Clinical Trial
Official title:
The Real World Study of Children With Autism Spectrum Disorder in China
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 |
The investigators conduct the real world study to explore mechanisms of autism based on multi-modal data.
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 |
Country | Name | City | State |
---|---|---|---|
China | ShanghaiXinhua | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
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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