People Presenting With Neurocysticercosis in North America

NCT02233855 | Terminated

• 2 other identifiers: 14019114-I-0191
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 4

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 sensation in the limbs. Researchers want to learn more about the different ways in which people in the United States present with this disease and how they respond to standard and newer treatments. Objective: \- To learn about the different forms of NCC that occurs throughout North America and how patients with these forms respond to treatment. Eligibility: \- Adults age 18 or older with NCC. Design:

• Participants will be screened with:
• Medical history and physical exam.
• A computed tomography (CT) brain scan The participant will lie still on a table that slides into a large donut-shaped scanner.
• Blood drawn through an arm vein for analysis
• A magnetic resonance imaging (MRI) scan of the brain and spine. They will lay flat in a long metal cylinder as the machine makes images of the body. During the scan, participants will receive a contrast agent through an IV that allows high resolution imaging of the brain and spine
• Participants will visit the clinic at 0, 1, 2, 3, 6, 12, and 24 months (7 times), and depending on the need for monitoring, more times. Participants will receive a schedule that will explain the procedures done at each visit.
• At these visits, participants may:
• Repeat the screening procedures.
• Be asked about their NCC symptoms and their physical and mental health.
• Have a urine test.
• Take a test of their ability to concentrate, their memory and spatial recognition.
• Have a lumbar puncture, if indicated by the state and severity of infection. A needle will be inserted through the skin and into the space between the bones in the back. Cerebrospinal fluid will be removed.

Conditions

Neurocysticercosis

Keywords

Seizures; Cestode; Hydrocephalus; Taenia Solium; Helminth

Outcome Measures

Primary Outcomes (1)

• The heterogeneity and complexity of the different forms of NCC will make it necessary to use different endpoints in analyzing the data collected from patients with each subtype of NCC. The endpoints listed here will be tailored and applied to th...

  Throughout the course of the study

Secondary Outcomes (10)

• To characterize the spectrum of diagnostic and treatment approaches across sites, including type and length of anthelmintic, anti-inflammatories, and anticonvulsants

  Throughout the course of the study.

• To determine exposure risks and estimate time to clinical symptomatic disease (incubation time) for each form of NCC

  Throughout the course of the study.

• For each form of NCC, to assess patient outcomes relative to: a) duration and type of anthelmintic therapy; b) duration and type of immunosuppressive therapy; and c) anticonvulsant therapy

  Throughout the course of the study.

• To correlate clinical features with radiographic findings at presentation, during treatment and follow-up for each form of NCC

  Throughout the course of the study.

• Determine proportion of patients with clinical and radiographic success 1 and 2 years after initiation of therapy. Definition of radiographic success will vary by form of NCC, but be based upon improvement followed by radiologic stability or slo...

  Throughout the course of the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \. 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.
• 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-

Sponsors & Collaborators

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

Study Sites (4)

University of California San Francisco

San Francisco, California, 94110, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related 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.

  PMID: 21912406 BACKGROUND

• Nash T. Edema surrounding calcified intracranial cysticerci: clinical manifestations, natural history, and treatment. Pathog Glob Health. 2012 Sep;106(5):275-9. doi: 10.1179/2047773212Y.0000000026.

  PMID: 23265551 BACKGROUND

• Fleury A, Carrillo-Mezo R, Flisser A, Sciutto E, Corona T. Subarachnoid basal neurocysticercosis: a focus on the most severe form of the disease. Expert Rev Anti Infect Ther. 2011 Jan;9(1):123-33. doi: 10.1586/eri.10.150.

  PMID: 21171883 BACKGROUND

MeSH Terms

Conditions

Neurocysticercosis; Seizures; Cestode Infections; Hydrocephalus; Taeniasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Siddhartha Mahanty, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2014
• First Posted: September 9, 2014
• Study Start: September 3, 2014
• Primary Completion: June 13, 2017
• Study Completion: June 13, 2017
• Last Updated: April 5, 2018

Record last verified: 2017-06-13

Locations

US (4)