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Идёт набор NCT06908174

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

— Наблюдательное Autism Spectrum Disorder Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: ADOS-2.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder, Healthy. Базовые параметры: 2 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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).

Подробное описание

The cross-sectional observational study will be performed to compare the differences of functional brain network and reactions to social stimulus between children with autism and typical development. The investigators will recruit children aged between 2 to 17 years and 11 months old. They need to receive the mentioned assessments and medical examinations for at least once.

Вмешательства

  • Диагностический тест ADOS-2
    The subjects in case group will receive the ADOS-2 assessment to confirm their diagnosis.

Первичные конечные точки

  • clinical diagnosis [Срок оценки: Baseline (during 2 to 17 years old).]
  • Latencies in event related potentials(ERPs) [Срок оценки: Baseline (during 2 to 17 years old).]
  • Amplitudes in ERPs [Срок оценки: Baseline (during 2 to 17 years old).]
  • nuclear magnetic resonance imaging(MRI) [Срок оценки: Baseline (during 2 to 17 years old).]
  • Changes in the concentrations of Oxygenated Hemoglobin (HbO) and deoxygenated Hemoglobin (HbR) during interactions [Срок оценки: Baseline (during 2 to 17 years old).]

Критерии участия

Case group:

Критерии включения

  • Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;
  • Ages 2-17 years;
  • Parents/caregivers understand the content of the study and agree to participate in.

Критерии исключения

  • Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;
  • Children with brain injuries, specific chronic or congenital diseases.
  • The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
  • Children cannot receive the head MRI examination.

Control group:

Критерии включения

  • Healthy children age between 2 to 17 years.
  • Children without the family history of ASD or other neurodevelopmental/mental diseases.
  • Parents/caregivers understand the content of the study and agree to participate in.

Критерии исключения

  • Children with brain injuries, specific chronic or congenital diseases.
  • The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.
  • Children cannot receive the head MRI examination.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT06908174 · brainpro2022-cross-sectional

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗