Natural History of Treated Neurocysticercosis and Long-Term Outcomes

June 2, 2026 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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....

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

1. Arms 1-5 (neurocysticercosis arms): male and female subjects over age 3 years with likely or definite neurocysticercosis (NCC) diagnosis 2. Arm 6 (endemic exposure arm): subjects 18 years or older with an epidemiologic history compatible with possible exposure to Taenia solium.

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Arm 1
Subarachnoid (racemose) neurocysticercosis
Arm 2
Ventricular without other viable disease
Arm 3
Parenchymal cyst(s)--non-calcified parenchymal disease at time of referral
Arm 4
Calcified parenchymal disease with symptoms (seizures)
Arm 5
Calcified parenchymal disease without symptoms
Arm 6
Endemic exposure--subjects with compatible epidemiologic exposure to T. solium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
Time Frame: Ongoing
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
Ongoing

Secondary Outcome Measures

Outcome Measure
Time Frame
Central and peripheral immune cell phenotyping and cytokine measurements
Time Frame: 2-5 years
2-5 years
Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.
Time Frame: 2-5 years
2-5 years
Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
Time Frame: Ongoing
Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Elise M O'Connell, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 1985

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimated)

November 4, 1999

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

March 9, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 850127
  • 85-I-0127

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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