Status:
TERMINATED
People Presenting With Neurocysticercosis in North America
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Neurocysticercosis
Eligibility:
All Genders
18+ years
Brief Summary
Background: \- Neurocysticercosis (NCC) is caused by tapeworms that infect people. NCC can lead to serious brain problems such as seizures, sevre headaches and difficulties with movements or sensatio...
Detailed Description
Neurocysticercosis (NCC) is the most common helminthic CNS infection and the main cause of adult-onset seizures in low-to-middle income countries. Studies have documented significant endemicity in Lat...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adults greater than or equal to18 years of age.
- Subject, or Subject s Legally Authorized Representative (LAR)/ Durable Power of Attorney (DPA), is able to provide informed consent and agree to allow samples to be stored for future research.
- Previously or currently diagnosed with definitive or probable NCC by a practitioner at NACC in accordance with the Del Brutto criteria modified for use in a North American populations.
- For the purpose of this study, definitive and probable diagnostic certainty based on presence of criteria below.
- Definitive diagnosis
- Presence of 1 absolute criterion
- Presence of 2 major + 1 minor + 1 epidemiological criterion
- Probable diagnosis Presence of 1 major + 2 minor criterion
- Presence of 1 major + 1 minor + 1 epidemiological criterion
- Presence of characteristic calcification(s)
- Del Brutto Diagnostic criteria
- Absolute criteria
- Biopsy of a brain or spinal cord lesion
- Cystic lesion with scolex on CT or MRI
- Fundoscopic examination (subretinal parasites)
- Major criteria
- Highly suggestive lesions on neuroimaging
- Positive serum enzyme-linked immunotransfer blot (EITB) assay
- Resolution of intracranial cysts after therapy
- Spontaneous resolution of small single enhancing lesions
- Minor criteria
- Compatible lesions on neuroimaging
- Clinical manifestations suggestive for NCC (eg, headaches, seizures, neurological symptoms)
- Positive CSF ELISA for specific Ag/Ab
- Cysts outside CNS
- Epidemiological criteria
- Evidence of household contact with T. solium
- Individuals coming from/living in endemic areas
- History of frequent travel to endemic areas
- Single or multiple characteristic calcifications in subjects who meet epidemiologic criteria (4) without another identifiable etiology will be considered NCC in the case of calcified granulomas
- EXCLUSION CRITERIA:
- 1\. Subjects that in the opinion of the investigator have contraindications for participation in the study will be excluded, such as patients with current substance abuse or patients currently undergoing cancer chemotherapy.
- Justification for Exclusion or Inclusion of Special Populations
- Children
- Children are eligible to participate in this clinical trial but will not be enrolled at the NIH because the NIH investigators do not see nor specialize in pediatric populations. In addition, NCC in the U.S. generally afflicts travelers and immigrants and is therefore exceedingly rare in pediatric populations in the U.S.
- Adults Unable To Provide Consent-
- Patients will be offered standard of care treatment delivered irrespective of cognitive status, including lumbar punctures that are used clinical management decisions as determined by the site PI. Exclusion of patients unable to provide consent because of cognitive impairment would limit the study population significantly, and potentially compromise the generalizability of results from this observational study. In cases where cognitive function precludes informed consent we will seek consent from the designated legal guardian.
Exclusion
Key Trial Info
Start Date :
September 3 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 13 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02233855
Start Date
September 3 2014
End Date
June 13 2017
Last Update
April 5 2018
Active Locations (4)
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1
University of California San Francisco
San Francisco, California, United States, 94110
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
3
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
4
University of Washington
Seattle, Washington, United States, 98195