跳至主要内容
临床试验/NCT06109337
NCT06109337招募中不适用

Immunoprofilling of Peripheral Blood Mononuclear Cells in Children With Attention Deficit/Hyperactivity Disorder

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
the differences in immune cell subpopulations, protein expression , signaling pathways between ADHD and typically developing children

研究概览

简要总结

The goal of this observational study is to learn about The immune cell landscape of peripheral blood mononuclear cells in children with ADHD compared to typically developing controls. The main question it aims to answer are: 1.Testing the differences in immune cell subpopulations, protein expression and signaling pathways and cell subsets between two groups 2. Exploring the correlations between immune function in PBMC and resting-state brain functional networks in children with ADHD.

Participants will be taken peripheral blood about 5 ml , cognitive assessment including Intelligence testing, Stroop color-word test and Trail making test, clinical interview and brain structural and functional MRI.

详细描述

3.1 Research Content Peripheral blood mononuclear cells of ADHD children and control group were taken, and 41 protein Marker on the cell surface was detected and analyzed by mass spectrometry flow cytometry (CyTOF) technology to draw a detailed map of ADHD immune cells, so as to explore the differences in protein expression level and subgroup distribution of immune cells between ADHD children and normal children. To evaluate the clinical symptoms, cognitive function, head MRI structure and resting state data of children with ADHD, and explore the correlation between immunophenotype and symptom score, cognition and brain structure.

3.2 Research Scheme 3.2.1 Collection of general and demographic data Demographic and clinical data, including name, age, sex, height, weight, age of first onset, course of disease, treatment, family history, past history and personal history, were collected by self-designed general situation scale.

3.2.2 Clinical evaluation The primary Clinical diagnosis was made by child psychiatrists with the title of attending psychiatrist or above through non-prescriptive clinical Interview, and the Clinical Diagnostic Interview Scale prepared by the American Working Group on Childhood Disorders was used. CDIS were conducted to evaluate ADHD classification, comorbidities, classification, comorbidities and clinical symptoms.

3.2.3 Core symptoms of ADHD ADHD-RS symptom assessment questionnaire was used to assess the severity of symptoms. The sum of scores of items in the attention deficit dimension is the attention deficit score, the sum of scores of items in the hyperactivity and impulsivity dimension is the score of hyperactivity impulse, and the sum of scores of all items is the score of the full scale. The higher the score, the more severe the symptoms.

3.2.4 Wechsler Intelligence test The Chinese children's Intelligence Scale (the third edition) was used to assess the IQ of the children.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of ADHD; Children with an IQ≥70; Both parents are Han; Agree to take venous blood with informed consent;

排除标准

  • Schizophrenia, mood disorder, autism, mental retardation; Obvious physical and nervous system abnormalities;

结局指标

主要结局

the differences in immune cell subpopulations, protein expression , signaling pathways between ADHD and typically developing children

时间窗: 2023.11.1-2023.12.31 Participant recruitment and deta collections

Blood samples of ADHD patients and normal control groups were collected, peripheral blood mononuclear cells were extracted, and 41 protein markers on cell surface were detected and analyzed by CyTOF technology, and detailed atlas of ADHD immune cells were drawn for immunological index analysis. These indicators include cytokine levels, immune cell subsets, and immune-related gene expression.

Clinical assessment and cognitive function testing

时间窗: 2023.11.1-2023.12.31 Participant recruitment and deta collections

The Clinical Diagnostic Interview Scale (CDIS) was used to evaluate ADHD types, comorbidities, types, comorbidities and clinical symptoms by child psychiatrists with the title of attending psychiatrist or above. ADHD-RS symptom assessment questionnaire was used to assess the severity of symptoms. Cognitive function tests include child IQ, Stroop color word naming test, and Trail making test (TMT).

Brain MRI structure and resting state data

时间窗: 2023.11.1-2023.12.31 Participant recruitment and deta collections

High-resolution brain structure images were acquired using 3D Magnetization Prepared Rapid Acquisition Gradient-echo (MPRAGE). The FMRI images were acquired by spin-echo-echo planar imaging (SE-EPI)

次要结局

  • General and demographic data collection(2023.11.1-2023.12.31 data collection)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验