Natural History of Treated Neurocysticercosis and Long-Term Outcomes
- Conditions
- CysticercosisNeurocysticercosis
- Registration Number
- NCT00001205
- Brief Summary
Neurocysticercosis is a brain disease due to the larval stage of the pork tapeworm (Taenia solium). The most common symptoms patient experience from infection inside the substance of the brain (parenchymal disease) are seizures and headaches. When the infection is either inside the fluid pockets inside the brain (ventricular disease) or in the space around the brain (subarachnoid disease) patients can have chronic headaches, relapsing aseptic meningitis, hydrocephalus, stroke, and may require neurosurgical intervention. The purpose of this study is to treat patients with anthelmintic therapy (praziquantel and/or albendazole) and anti-inflammatories in alignment with currently accepted best practices and guidelines, depending on the neurocysticercosis subtype. The purpose of the study is to better understand and characterize clinical, biologic, and management factors during treatment that influence long term outcomes. In order to understand this further we collect patient information, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care....
- Detailed Description
Study Description:
The purpose of this protocol is to follow participants with cysticercosis during and after completion of treatment, to characterize the disease course during both short- and long-term follow-up, assess biomarkers associated with infection and response to treatment, improve diagnostic assays, and explore host-parasite interactions.
Primary Objective:
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
Secondary Objectives:
1. To develop novel biomarkers associated with active infection
2. To further understand host-parasite interactions, including the inflammatory response
3. Understand the basis for the pleiomorphic clinical manifestations, including the possible contributions of parasite and host genetics
4. Develop a screening paradigm
Primary Endpoint:
Description of clinical presentation, imaging features, morbidity, response to treatment, and outcomes in all forms of NCC.
Secondary Endpoints:
1. Central and peripheral immune cell phenotyping and cytokine measurements
2. Including, but not limited to bulk transcriptomics, referral to study for participant whole genome sequencing, cestode-specific genome sequencing
3. Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
4. Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterise the radiographic, biochemical, and clinical course of neurocysticercosis during and after treatment with long-term follow-up, with the goal of documenting a disease free state off anthelmintics for 7 years 7 years-indefinite To study the clinical course of cysticercosis following therapy and diminish morbidity associated with treatment of cysticercosis including neurocysticercosis or the inflammation associated with therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States