ADHD Clinical Trial
Official title:
Immunoprofilling of Peripheral Blood Mononuclear Cells in Children With Attention Deficit/Hyperactivity Disorder
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: Clinical diagnosis of ADHD; Children with an IQ=70; Both parents are Han; Agree to take venous blood with informed consent; Exclusion Criteria: Schizophrenia, mood disorder, autism, mental retardation; Obvious physical and nervous system abnormalities; |
Country | Name | City | State |
---|---|---|---|
China | Fu Guanghui | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University |
China,
Darwish AH, Elgohary TM, Nosair NA. Serum Interleukin-6 Level in Children With Attention-Deficit Hyperactivity Disorder (ADHD). J Child Neurol. 2019 Feb;34(2):61-67. doi: 10.1177/0883073818809831. Epub 2018 Nov 15. — View Citation
Ni Chasaide C, Lynch MA. The role of the immune system in driving neuroinflammation. Brain Neurosci Adv. 2020 Jan 29;4:2398212819901082. doi: 10.1177/2398212819901082. eCollection 2020 Jan-Dec. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the differences in immune cell subpopulations, protein expression , signaling pathways between ADHD and typically developing children | 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. | 2023.11.1-2023.12.31 Participant recruitment and deta collections | |
Primary | Clinical assessment and cognitive function testing | 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). | 2023.11.1-2023.12.31 Participant recruitment and deta collections | |
Primary | Brain MRI structure and resting state data | 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) |
2023.11.1-2023.12.31 Participant recruitment and deta collections | |
Secondary | General and demographic data collection | A comprehensive questionnaire included name, age, sex, height, weight, age of first onset, course of disease, treatment, family history, past history, personal history | 2023.11.1-2023.12.31 data collection |
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