Actively Recruiting
Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis
Led by Shanghai Mental Health Center · Updated on 2024-11-08
360
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to identify diagnostic biomarkers for neurosyphilis in patients with the condition. The main questions it aims to answer are: What plasma biomarkers are associated with neurosyphilis? What electrophysiological characteristics (EEG and eye movement) are linked to neurosyphilis? Researchers will compare biomarker data from plasma and gut microbiome analyses with electrophysiological findings to see if these factors can help diagnose neurosyphilis. Participants will: Provide clinical information such as age, gender, symptoms, and disease course Submit blood and urine samples for proteomics and metagenomic sequencing Undergo EEG and eye movement evaluations for electrophysiological analysis
CONDITIONS
Official Title
Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with neurosyphilis based on CDC 2015 and 2020 European guidelines, including positive serological and cerebrospinal fluid tests
- Patients with syphilis but not meeting neurosyphilis diagnostic criteria
- Healthy individuals with no mental or organ diseases
- Age between 18 and 65 years
- At least junior high school education
- Adequate hearing and vision to complete study assessments
- No contraindications for EEG (all participants) and TMS (neurosyphilis patients)
You will not qualify if you...
- Age under 18 or over 65 years
- Pregnant or breastfeeding women
- HIV-positive status
- Severe primary diseases such as liver, kidney, endocrine, hematological diseases with autoimmune or connective tissue diseases
- Other central nervous system diseases besides neurosyphilis
- Contraindications for TMS including history of head trauma, epilepsy, or metal implants (for neurosyphilis and syphilis patients)
- Contraindications for EEG such as severe scalp injuries, open cranial trauma, inability to place electrodes, or risk of infection
- Education level below junior high school
- Severe physical illnesses or major organ diseases (for healthy controls)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
X
Xiaoyun Guo, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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