Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis

Launched by SHANGHAI MENTAL HEALTH CENTER · Nov 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying neurosyphilis, which is a type of syphilis that affects the nervous system. The researchers want to find out more about specific markers in the blood that can help diagnose this condition. They will look at blood samples and conduct tests on brain activity and eye movements to see if these factors are connected to neurosyphilis. By understanding these connections, the study aims to improve how we diagnose this illness.

To participate, you need to be between 18 and 65 years old and meet certain health criteria, such as having a confirmed diagnosis of neurosyphilis or other types of syphilis. Participants will provide information about their health, give blood and urine samples, and undergo tests that measure brain activity and eye movements. It's important to know that some people may not be eligible, especially if they have severe health issues or certain conditions that could interfere with the tests. If you're interested or think you might qualify, this study could help improve the understanding and diagnosis of neurosyphilis.

Gender

ALL

Eligibility criteria

• 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.