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

NCT06109337 | Recruiting DMC

• 1 other identifier: FirstZhejiangU-fgh01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD; Immune System; Clinical Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• General and demographic data collection

  2023.11.1-2023.12.31 data collection

Study Arms (2)

ADHD children

Take peripheral blood 5ml; IQ and cognitive function test; Head MRI scan

Diagnostic Test: drow blood

typically developing controls

Take peripheral blood 5ml; IQ and cognitive function test; Head MRI scan

Diagnostic Test: drow blood

Interventions

drow blood DIAGNOSTIC_TEST

Participants will be taken peripheral blood about 5 ml

ADHD children; typically developing controls

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children and teenagers ages 6-12 years

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Fu Guanghui

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 32219178 RESULT

• 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.

  PMID: 30430896 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood monocyte

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hu Guanghui, doctor

  Department of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hu Shaohua, doctor

CONTACT

13957162903; dorhushaohua@zju.edu.cn

Fu Guanghui, doctor

CONTACT

18801170914; fuguanghui@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 31, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 1, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)