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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to identify diagnostic biomarkers for neurosyphilis by examining plasma biomarkers and electrophysiological characteristics, including EEG and eye movement. The study aims to understand which biomarkers and electrophysiological findings are linked to neurosyphilis and how these can assist in diagnosis. Participants include neurosyphilis patients, non-neurosyphilis syphilis patients, and healthy controls. They will provide clinical information such as age, gender, symptoms, and disease course. Blood and urine samples will be collected for proteomics and metagenomic sequencing, and EEG and eye movement evaluations will be performed for electrophysiological analysis. Participants will be assessed at baseline, 6 months, and 12 months for AIM2 inflammasome in blood and NFL and sTREM2 in cerebrospinal fluid. Cognitive function will also be evaluated at baseline and 6 months using the MoCA test. The study includes monitoring for safety and adherence to assessments over these time points.
CONDITIONS
Brief Title
Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the diagnostic criteria for neurosyphilis based on CDC and European guidelines, including positive serological and cerebrospinal fluid tests
- Aged 18 to 65 years, any gender
- At least a junior high school education level
- Sufficient hearing and vision to complete study assessments
- No contraindications for EEG and transcranial magnetic stimulation (TMS)
You will not qualify if you...
- Age below 18 years or above 65 years
- Pregnant or breastfeeding women
- HIV-positive status
- Severe primary diseases such as liver, kidney, endocrine, or blood disorders 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
- Contraindications for EEG, such as severe scalp injuries or inability to place electrodes
- Education level below junior high school
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo diagnostic assessments including serological and cerebrospinal fluid tests to confirm neurosyphilis status and eligibility.
1 visit (in-person)
Duration - 12 months
Participants have blood and cerebrospinal fluid samples collected and cognitive function assessed at multiple time points to monitor biomarkers and cognitive changes over time.
Visits at baseline, 6 months, and 12 months after enrollment
Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
X
Xiaoyun Guo, PhD
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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