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Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00001205
Enrollment
500
Registered
1999-11-04
Start date
1985-10-07
Completion date
Unknown
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cysticercosis, Neurocysticercosis

Keywords

Tapeworm, Taenia Solium, Neurocysticercosis, Natural History, Seizures, Aseptic Meningitis, Hydrocephalus

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 clinical information, patient survey responses, 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.

Interventions

None listed

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 99 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.OngoingTo 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

MeasureTime frame
Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.2-5 years
Biobanking cerebrospinal fluid (CSF), serum, plasma, urineOngoing
Central and peripheral immune cell phenotyping and cytokine measurements2-5 years

Countries

United States

Contacts

CONTACTPerla M Adames Castillo, R.N.
perla.adamescastillo@nih.gov(301) 402-8495
CONTACTElise M O'Connell, M.D.
oconnellem@mail.nih.gov(301) 761-5413
PRINCIPAL_INVESTIGATORElise M O'Connell, M.D.

National Institute of Allergy and Infectious Diseases (NIAID)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026