NCT06908174 Differences in Prosocial Behaviors and Related Brain Networks in Children With Autism and Typical Development
| NCT ID | NCT06908174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Autism Spectrum Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-04-07 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Xiu Xu
PRINCIPAL INVESTIGATOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06908174 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06908174 currently recruiting?
Yes, NCT06908174 is actively recruiting participants. Contact the research team at zbr1800@163.com for enrollment information.
Where is the NCT06908174 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06908174 clinical trial?
NCT06908174 is sponsored by Children's Hospital of Fudan University. The principal investigator is Xiu Xu at Children's Hospital of Fudan University. The trial plans to enroll 300 participants.