People Presenting With Neurocysticercosis in North America
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|ClinicalTrials.gov Identifier: NCT02233855|
Recruitment Status : Terminated
First Posted : September 9, 2014
Last Update Posted : April 5, 2018
- 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.
- To learn about the different forms of NCC that occurs throughout North America and how patients with these forms respond to treatment.
- Adults age 18 or older with NCC.
- 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.
|Condition or disease|
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 Latin America, Eastern Europe, sub-Saharan Africa, India and other parts of the world. The prevalence of NCC in North America is rising as a result of increased migration of people with the disease and, occasionally, immigration of individuals with asymptomatic tapeworms. Despite the gains in knowledge and understanding of the epidemiology, pathophysiology, diagnosis, and treatment, clinical care continues to be hampered by unanswered fundamental questions related to optimal diagnosis, staging, treatment, and follow-up of patients with NCC.
This multi-center, natural history study seeks to characterize: the frequency of the various forms of NCC in North American populations; the spectrum of treatment and management strategies across the North American Cysticercosis Consortium; and the response to therapy by evaluating a number of endpoints related to disease evolution and treatment, such as burden of disease, cognitive changes, radiographic changes, and treatment complications. This study will inform future research studies needed to eventually establish standardized management protocols for each form of this complex infection.
Subjects will have visits at screening, baseline, 1, 2 (optional), 3, 6, 12, and 24 months. Evaluations will include assessment of clinical status, antigen assays, radiographic imaging, functional assessments, immunologic evaluations, cognitive assessments, and quality of life measures. Additional clinically indicated visits may be scheduled as needed. This study does not provide any interventional therapies but will collect data on the course of treatment. Diagnostic examinations, consultations and medical treatment will be determined by the study clinician. Any samples removed for medical indications related to NCC may be evaluated for research purposes.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||NACC 002: A Multicenter Prospective Natural History Study of Patients Presenting With Neurocysticercosis in North America|
|Study Start Date :||September 3, 2014|
|Actual Primary Completion Date :||June 13, 2017|
|Actual Study Completion Date :||June 13, 2017|
- 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... [ Time Frame: Throughout the course of the study ]
- To characterize the spectrum of diagnostic and treatment approaches across sites, including type and length of anthelmintic, anti-inflammatories, and anticonvulsants [ Time Frame: Throughout the course of the study. ]
- To determine exposure risks and estimate time to clinical symptomatic disease (incubation time) for each form of NCC [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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... [ Time Frame: Throughout the course of the study. ]
- To enumerate complications associated with NCC or treatment type for each form of NCC [ Time Frame: Throughout the course of the study. ]
- To characterize and correlate the clinical features, radiographic findings, antigen presence and levels, and antibody responses for NCC with perilesional edema [ Time Frame: Throughout the course of the study. ]
- To assess diagnostic parameters of serology and antigen detection assays in North American patients [ Time Frame: Throughout the course of the study. ]
- To correlate antigen levels in serum and CSF with burden of disease and recurrence of disease in subjects with NCC [ Time Frame: Throughout the course of the study. ]
- To characterize cognitive function at baseline, 6, 12, and 24 months as assessed by the Montreal Cognitive Assessment (MOCA) test [ Time Frame: Throughout the course of the study. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233855
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94110|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Texas|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Siddhartha Mahanty, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|