🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06680011
Recruiting Observational

Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis

NCT06680011 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Mental Health Center
Phase
Observational
Started
2024-04-01
Last updated
2024-11-08

Condition(s) studied

NeurosyphilisBiomarkersProteomics

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Neurosyphilis Patients 1. Meet the diagnostic criteria for neurosyphilis in this study based on the 2015 Sexually Transmitted Diseases Treatment Guidelines published by the Centers for Disease Control and Prevention (CDC) and the 2020 European Guideline on the Management of Syphilis: ① Positive serological tests for Treponema pallidum (e.g., Treponemal tests) and rapid plasma reagin (RPR) tests; ② Positive cerebrospinal fluid tests for Treponema pallidum particle agglutination assay (TPPA), the toluidine red unheated serum test (TRUST), and the Venereal Disease Research Laboratory test (VDRL). 2. Aged 18-65 years, regardless of gender (female patients are rare in clinical practice). 3. At least a junior high school education level, with sufficient auditory and visual function to complete the necessary examinations and assessments for this study. 4. No contraindications for electroencephalogram (EEG) and transcranial magnetic stimulation (TMS). * Non-neurosyphilis Syphilis Patients 1. Positive serological tests for Treponema pallidum (e.g., Treponemal tests) and rapid plasma reagin (RPR) tests. 2. Does not meet the diagnostic criteria for neurosyphilis in this study, based on the 2015 Sexually Transmitted Diseases Treatment Guidelines published by the Centers for Disease Control and Prevention (CDC) and the 2020 European Guideline on the Management of Syphilis: ① Positive serological tests for Treponema pallidum and rapid plasma reagin tests; ② Positive cerebrospinal fluid tests for Treponema pallidum particle agglutination assay (TPPA), the toluidine red unheated serum test (TRUST), and the Venereal Disease Research Laboratory test (VDRL). 3. Aged 18-65 years, regardless of gender (female patients are rare in clinical practice). 4. At least a junior high school education level, with sufficient auditory and visual function to complete the necessary examinations and assessments for this study. 5. No contraindications for electroencephalogram (EEG). * Healthy Controls 1. Physically healthy (no mental illnesses or diseases affecting bodily organs). 2. Aged 18-65 years, regardless of gender. 3. At least a junior high school education level, with sufficient auditory and visual function to complete the necessary examinations and assessments for this study. 4. No contraindications for electroencephalogram (EEG). Exclusion Criteria: * Neurosyphilis Patients \& Non-neurosyphilis Syphilis Patients 1. Age \< 18 years or \> 65 years; 2. Pregnant or breastfeeding women (female patients are rare in clinical practice); 3. HIV-positive; 4. Presence of severe primary diseases (such as liver, kidney, endocrine, or hematological diseases) accompanied by autoimmune diseases or connective tissue diseases; 5. Presence of other central nervous system diseases besides neurosyphilis; 6. Contraindications for transcranial magnetic stimulation (TMS) treatment, such as history of head trauma, epilepsy, or presence of metal implants; 7. Contraindications for electroencephalography (EEG), such as severe scalp injuries, extensive or open cranial trauma, inability to place electrodes, or potential for infection from the examination. 8. Education level below junior high school. * Healthy Controls 1. Age \< 18 years or \> 65 years; 2. Pregnant or breastfeeding women; 3. HIV-positive; 4. Other central nervous system diseases, severe physical illnesses, or major organ diseases; 5. Presence of severe primary diseases (such as liver, kidney, endocrine, or hematological diseases) accompanied by autoimmune diseases or connective tissue diseases; 6. Contraindications for electroencephalography (EEG), such as severe scalp injuries, extensive or open cranial trauma, inability to place electrodes, or potential for infection from the examination; 7. Education level below junior high school.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Mental Health Center Shanghai Shanghai Municipality Recruiting

More Shanghai Mental Health Center trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06680011 on ClinicalTrials.gov ↗ ← All trials in China