An observational study in Neurocysticercosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
Background:
Objective:
Eligibility:
Design:
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.
21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.
Browse Neurocysticercosis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults greater than or equal to18 years of age.
For the purpose of this study, definitive and probable diagnostic certainty based on presence of criteria below.
Definitive diagnosis
Probable diagnosis Presence of 1 major + 2 minor criterion
Del Brutto Diagnostic criteria
Absolute criteria
Major criteria
Minor criteria
Epidemiological criteria
EXCLUSION CRITERIA:
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 we will seek consent from the designated legal guardian.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The record gives a start of Sep 2014, a primary completion of Jun 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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