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NCT Number: NCT00001205

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

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....

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Key information

Conditions

Cysticercosis Brain Diseases Central Nervous System Diseases Central Nervous System Helminthiasis Central Nervous System Infections Central Nervous System Parasitic Infections Cestode Infections Helminthiasis Hydrocephalus Infections Meningitis Meningitis, Aseptic Nervous System Diseases Neurocysticercosis Neuroinflammatory Diseases Neurologic Manifestations Parasitic Diseases Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Taeniasis

Age range

3 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location status: Recruiting

About this study

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:

  • To develop novel biomarkers associated with active infection
  • To further understand host-parasite interactions, including the inflammatory response
  • Understand the basis for the pleiomorphic clinical manifestations, including the possible contributions of parasite and host genetics
  • 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:

  • Central and peripheral immune cell phenotyping and cytokine measurements
  • Including, but not limited to bulk transcriptomics, referral to study for participant whole genome sequencing, cestode-specific genome sequencing
  • Biobanking cerebrospinal fluid (CSF), serum, plasma, urine
  • Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

Arms 1-5 (NCC):

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

Arm 6 (Endemic Exposures):

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

Exclusion criteria

Not applicable

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Central and peripheral immune cell phenotyping and cytokine measurements

    Time frame: 2-5 years

  2. Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.

    Time frame: 2-5 years

  3. Biobanking cerebrospinal fluid (CSF), serum, plasma, urine

    Time frame: Ongoing

Study contacts

Contact information is provided by the study sponsor or research team.

Elise M O'Connell, M.D.

CONTACT

[email protected]

(301) 761-5413

Perla M Adames Castillo, R.N.

CONTACT

[email protected]

(301) 402-8495

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Important dates

Study start
1985
First posted
Nov 4, 1999
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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