Natural History of Treated Neurocysticercosis and Long-Term Outcomes

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Enrolling

Conditions: Neurocysticercosis; Cysticercosis

Study type: Observational

Funder types: NIH

Identifiers

NCT00001205

85-I-0127

850127

Details and patient eligibility

About

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 clinical information, patient survey responses, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care....

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 3 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• INCLUSION CRITERIA:

Arms 1-5 (NCC):

1. Aged 3 years and older.
2. Ability of participant (or legally authorized representative, LAR) to understand and the willingness to sign a written informed consent document.
3. Patients with proven or likely NCC

Arm 6 (Endemic Exposures):

1. Patient with epidemiologic history compatible with possible exposure to NCC
2. Aged 18 years and older.

EXCLUSION CRITERIA:

Not applicable

Trial design

500 participants in 6 patient groups

Arm 1

Description:

Subarachnoid (racemose) neurocysticercosis

Arm 2

Description:

Ventricular without other viable disease

Arm 3

Description:

Parenchymal cyst(s)--non-calcified parenchymal disease at time of referral

Arm 4

Description:

Calcified parenchymal disease with symptoms (seizures)

Arm 5

Description:

Calcified parenchymal disease without symptoms

Arm 6

Description:

Endemic exposure--subjects with compatible epidemiologic exposure to T. solium