ADOS-2: The subjects in case group will receive the ADOS-2 assessment to confirm their diagnosis.
Study summary
The goal of this observational study is to compare the brain functional network between children with autism and typical development, using magnetic resonance imaging (MRI), electroencephalogram/event-related potentials(EEG/ERPs) and functional Near Infrared Spectrum(fNIRs). The main questions it aims to answer are as follows: 1. What are the differences of the functional brain network between autism and TD children? 2. What are the differences of the brain activity in response to special social stimulus between autism and TD children? Participants will receive developmental/intelligence assessments (Griffiths Mental Developmental Scales/Wechsler Preschool and Primary Scale of Intelligence-IV/Wechsler Intelligence Scale for Children-IV for children of different ages), social assessments(Autism Diagnostic Observation Schedule-2nd Edition/Social Communication Questionnaire), EEG/ERPs and fNIRs in resting and task states, and head MRI in natural sleeping state(without sedative).
Eligibility
Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
Accepted
Case group:
Inclusion Criteria:
1. Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
2. Ages 2-17 years;
3. Parents/caregivers understand the content of the study and agree to participate in.
Exclusion Criteria:
1. Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
2. Children with brain injuries, specific chronic or congenital diseases.
3. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
4. Children cannot receive the head MRI examination.
Control group:
Inclusion Criteria:
1. Healthy children age between 2 to 17 years.
2. Children without the family history of ASD or other neurodevelopmental/mental diseases.
3. Parents/caregivers understand the content of the study and agree to participate in.
Exclusion Criteria:
1. Children with brain injuries, specific chronic or congenital diseases.
2. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
3. Children cannot receive the head MRI examination.
Primary outcome measure(s)
clinical diagnosis — Baseline (during 2 to 17 years old). Clinicians will diagnose subjects as ASD, other neurodevelopmental disorders, or typical developing children, using DSM-5 and ADOS-2. The minimum and maximum scores of ADOS-2 are 0 and 28, and the comparison score of ADOS-2 ranges from 1 to 10, in which higher scores mean a worse outcome.
Latencies in event related potentials(ERPs) — Baseline (during 2 to 17 years old). The investigators will explore the differences of N1/N2, P3/LPP and N400 in event related potentials (ERPs) between case and control groups (children with ASD and typical development) in responses to special prosocial stimulus, and also in false belief tasks. Event related potentials (ERPs) will be tested using eego™ mylab of ANT Neuro company.
Amplitudes in ERPs — Baseline (during 2 to 17 years old). Amplitudes of N1/N2, P3/LPP and N400 will be compared between children with autism spectrum disorder and typical development.
nuclear magnetic resonance imaging(MRI) — Baseline (during 2 to 17 years old). Cranial MRI data, including sMRI and fMRI, will be collected during subjects are in natural asleep or awake, using uMR 890 3T of United Imaging company.
Changes in the concentrations of Oxygenated Hemoglobin (HbO) and deoxygenated Hemoglobin (HbR) during interactions — Baseline (during 2 to 17 years old). The investigators will explore inter-group differences of children with ASD and typical development in the concentrations of HbO and HbR during social communication scenes between participants and investigators.
Trial sites (1)
Facility
City
Region
Status
Children's Hospital of Fudan University
Shanghai
China
Recruiting
More Children's Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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