Comparing brain networks in children with autism and typical development

Differences in Prosocial Behaviors and Related Brain Networks in Children With Autism and Typical Development

This study looks at how the brains of children with autism work differently from those of children without autism to see how they respond to social situations.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: Children's Hospital of Fudan University (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06908174 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the differences in brain functional networks between children diagnosed with Autism Spectrum Disorder (ASD) and those with typical development. Utilizing advanced imaging techniques such as MRI, EEG/ERPs, and fNIRs, the study will assess brain activity in response to social stimuli and conduct developmental and social assessments. Participants aged 2 to 17 years will undergo these evaluations to better understand the neurobiological underpinnings of prosocial behaviors in both groups.

Who should consider this trial

Good fit: Ideal candidates include children aged 2 to 17 years diagnosed with ASD or healthy children without a family history of neurodevelopmental disorders.

Not a fit: Patients with genetic syndromes, significant brain injuries, or those unable to undergo MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of autism and inform targeted interventions to improve social functioning in affected children.

How similar studies have performed: Other studies have shown promising results in understanding brain differences in autism, suggesting this approach is supported by existing research.

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.

Where this trial is running

Shanghai

• Children's Hospital of Fudan University — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Xiu Xu — Children's Hospital of Fudan University
• Study coordinator: Bingrui Zhou

Conditions: Autism Spectrum Disorder, Healthy, autism