Natural History of Treated Neurocysticercosis and Long-Term Outcomes

NCT00001205 | Recruiting

• 2 other identifiers: 85012785-I-0127
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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....

Conditions

Cysticercosis; Neurocysticercosis

Keywords

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

Outcome Measures

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.

  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 Outcomes (3)

• Central and peripheral immune cell phenotyping and cytokine measurements

  2-5 years

• 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, urine

  Ongoing

Study Arms (6)

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

Eligibility Criteria

• Age: 3 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (9)

• McAleese KR, Guzman JJ, Thumm L, Nutman TB, Showler A, O'Connell EM. Chagas Disease Prevalence in a Cohort of Neurocysticercosis Patients in a Nonendemic Setting. Clin Infect Dis. 2022 Sep 14;75(5):897-900. doi: 10.1093/cid/ciac076.

  PMID: 35134144 BACKGROUND

• Beatty NL, Kaur H, Schlaffer K, Thompson K, Manavalan P, Rijos ZR, Raman AA, Droghini HR, O'Connell EM. Subarachnoid Neurocysticercosis Case Series Reveals a Significant Delay in Diagnosis-Requiring a High Index of Suspicion Among Those at Risk. Open Forum Infect Dis. 2024 Mar 21;11(5):ofae176. doi: 10.1093/ofid/ofae176. eCollection 2024 May.

  PMID: 38680612 BACKGROUND

• Tang NL, Nash TE, Corda M, Nutman TB, O'Connell EM. Triplex ELISA for Assessing Durability of Taenia solium Seropositivity after Neurocysticercosis Cure. Emerg Infect Dis. 2023 Jul;29(7):1340-1348. doi: 10.3201/eid2907.230364.

  PMID: 37347506 BACKGROUND

• Corda M, Sciurba J, Blaha J, Mahanty S, Paredes A, Garcia HH, Nash TE, Nutman TB, O'Connell EM. A recombinant monoclonal-based Taenia antigen assay that reflects disease activity in extra-parenchymal neurocysticercosis. PLoS Negl Trop Dis. 2022 May 26;16(5):e0010442. doi: 10.1371/journal.pntd.0010442. eCollection 2022 May.

  PMID: 35617367 BACKGROUND

• Harrison S, Thumm L, Nash TE, Nutman TB, O'Connell EM. The Local Inflammatory Profile and Predictors of Treatment Success in Subarachnoid Neurocysticercosis. Clin Infect Dis. 2021 May 4;72(9):e326-e333. doi: 10.1093/cid/ciaa1128.

  PMID: 33269789 BACKGROUND

• Nash TE, O'Connell EM. Subarachnoid neurocysticercosis: emerging concepts and treatment. Curr Opin Infect Dis. 2020 Oct;33(5):339-346. doi: 10.1097/QCO.0000000000000669.

  PMID: 32868512 BACKGROUND

• Tang NL, Schaughency P, Gazzinelli-Guimaraes P, Lack J, Thumm L, Miltenberger E, Nash TE, Nutman TB, O'Connell EM. Immunologic Profiling of CSF in Subarachnoid Neurocysticercosis Reveals Specific Interleukin-10-Producing Cell Populations During Treatment. Neurol Neuroimmunol Neuroinflamm. 2024 Nov;11(6):e200320. doi: 10.1212/NXI.0000000000200320. Epub 2024 Oct 30.

  PMID: 39475624 BACKGROUND

• Nash TE, O'Connell EM, Hammoud DA, Wetzler L, Ware JM, Mahanty S. Natural History of Treated Subarachnoid Neurocysticercosis. Am J Trop Med Hyg. 2020 Jan;102(1):78-89. doi: 10.4269/ajtmh.19-0436.

  PMID: 31642423 BACKGROUND

• O'Connell EM, Harrison S, Dahlstrom E, Nash T, Nutman TB. A Novel, Highly Sensitive Quantitative Polymerase Chain Reaction Assay for the Diagnosis of Subarachnoid and Ventricular Neurocysticercosis and for Assessing Responses to Treatment. Clin Infect Dis. 2020 Apr 15;70(9):1875-1881. doi: 10.1093/cid/ciz541.

  PMID: 31232448 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cysticercosis; Neurocysticercosis; Cestode Infections; Taeniasis; Seizures; Meningitis, Aseptic; Hydrocephalus

Condition Hierarchy (Ancestors)

Helminthiasis; Parasitic Diseases; Infections; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Meningitis; Neuroinflammatory Diseases; Brain Diseases

Study Officials

• Elise M O'Connell, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Perla M Adames Castillo, R.N.

CONTACT

(301) 402-8495; perla.adamescastillo@nih.gov

Elise M O'Connell, M.D.

CONTACT

(301) 761-5413; oconnellem@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: October 7, 1985
• Last Updated: April 29, 2026

Record last verified: 2026-03-09

Locations

US (1)