People Presenting With Neurocysticercosis in North America
Stopped early
Conditions studied: Neurocysticercosis
In brief
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.
Key facts
- Study ID
- NCT02233855
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 11
- Starts
- 2014-09-03
- Expected to finish
- 2017-06-13
- Last updated by the study team
- 2018-04-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
- 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.
Where it is running
- University of California San Francisco — San Francisco, California, United States
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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