Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Neurocysticercosis Clinical Trial

Official title:

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00001205
• Other study ID #: 850127
• Secondary ID: 85-I-0127
• Status: Recruiting
• Start date: October 7, 1985

Study information

• Verified date: June 17, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Perla M Adames Castillo, R.N.
• Phone: (301) 402-8495
• Email: perla.adamescastillo[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

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

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. Cysticercosis is defined as an infection with the larval form of Taenia solium and includes infection of the brain (neurocysticercosis [NCC]) that accounts for most of the symptomatic disease and serious complications. Evaluation and treatment will be provided as clinically indicated. Clinical data and biospecimens will be collected during and after treatment to assess biomarkers of infection and inflammation, immunologic response to treatment, and correlations between biomarkers and results of clinically indicated diagnostic tests. In addition, we will collect information from patient-reported outcome questionnaires completed by participants to better understand the long-term effect on functional ability and determine if there is a correlation between clinical deficits with biomarkers of inflammation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 99 Years

Eligibility

• INCLUSION CRITERIA:

1. Patients ages 3 to 99 years.

2. Patients with proven or likely neurocysticercosis.

3. Willingness (of participant or legally authorized representative [LAR]) to sign consent and comply with study requirements.

EXCLUSION CRITERIA:

Not applicable.

Related Conditions & MeSH terms

• Cysticercosis
• Neurocysticercosis

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

Nash TE, Singh G, White AC, Rajshekhar V, Loeb JA, Proano 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. doi: 10.1212/01.wnl.0000238514.51747.3a. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterise the radiographic, biochemical, and clinical course of neurocysticercosis during and after treatment with long term follow up, with the goal of documenting a disease free state off anthelmintics for 7 years	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	7 years-indefinite

External Links

•   NIH Clinical Center Detailed Web Page