Protocol Details

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	85-I-0127
Sponsoring Institute	National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 3 Years Max Age: 99 Years
Referral Letter Required	No
Population Exclusion(s)	None
Keywords	Tapeworm; Taenia Solium; Neurocysticercosis; Natural History; Seizures; Aseptic Meningitis; Hydrocephalus
Recruitment Keyword(s)	None
Condition(s)	Cysticercosis; Neurocysticercosis
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Allergy and Infectious Diseases

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

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Eligibility

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

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Citations:

Nash TE, Singh G, White AC, Rajshekhar V, Loeb JA, Proa(SqrRoot) o JV, Takayanagui OM, Gonzalez AE, Butman JA, DeGiorgio C, Del Brutto OH, Delgado-Escueta A, Evans CA, Gilman RH, Martinez SM, Medina MT, Pretell EJ, Teale J, Garcia HH. Treatment of neurocysticercosis: current status and future research needs. Neurology. 2006 Oct 10;67(7):1120-7.

Nash TE, Mahanty S, Garcia HH; Cysticercosis Group in Peru. Corticosteroid use in neurocysticercosis. Expert Rev Neurother. 2011 Aug;11(8):1175-83. doi: 10.1586/ern.11.86.

Nash TE, Garcia HH. Diagnosis and treatment of neurocysticercosis. Nat Rev Neurol. 2011 Sep 13;7(10):584-94. doi: 10.1038/nrneurol.2011.135. Review.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Elise M. O'Connell, M.D. National Institute of Allergy and Infectious Diseases (NIAID) NIHBC 04 BG RM 424 4 MEMORIAL DR BETHESDA MD 20892 (301) 761-5413 oconnellem@mail.nih.gov	Perla M. Adames Castillo, R.N. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 6D44 10 Center Drive Bethesda, Maryland 20892 (301) 402-8495 perla.adamescastillo@nih.gov	Office of Patient Recruitment National Institutes of Health Clinical Center (CC) Building 61, 10 Cloister Court Bethesda, Maryland 20892 Toll Free: 1-800-411-1222 Local Phone: 301-451-4383 TTY: TTY Users Dial 7-1-1 ccopr@nih.gov

Clinical Trials Number:

NCT00001205

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