NeurocysticercosisNCT02233855
People Presenting With Neurocysticercosis in North America
An observational study of Neurocysticercosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurocysticercosis
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Sep 2014to 13 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 30Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
UT Southwestern Medical Center
Dallas, Texas, 75390
University of California San Francisco
San Francisco, California, 94110
University of Washington
Seattle, Washington, 98195
About this study
Official title: NACC 002: A Multicenter Prospective Natural History Study of Patients Presenting With Neurocysticercosis in North America
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.
Read more
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.
Read the 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 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.
- Conditions
- Neurocysticercosis
- Keywords
- Seizures, Cestode, Hydrocephalus, Taenia Solium, Helminth
- Medical subject headings
- Neurocysticercosis, Seizures, Cestode Infections, Hydrocephalus, Taeniasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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...
Measured: 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
Measured: Throughout the course of the study.
To determine exposure risks and estimate time to clinical symptomatic disease (incubation time) for each form of NCC
Measured: 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
Measured: 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
Measured: 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...
Measured: Throughout the course of the study.
To enumerate complications associated with NCC or treatment type for each form of NCC
Measured: 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
Measured: Throughout the course of the study.
To assess diagnostic parameters of serology and antigen detection assays in North American patients
Measured: 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
Measured: 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
Measured: Throughout the course of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start3 Sep 2014
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeurocysticercosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Siddhartha Mahanty, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233855
- Sponsor's protocol ID
- 140191
- Other IDs
- 14-I-0191
- Status last verified
- 13 Jun 2017
- First submitted
- 6 Sep 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
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.
PubMed 21912406Nash 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.
PubMed 23265551Fleury 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.
PubMed 21171883
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NACC 002: A Multicenter Prospective Natural History Study of Patients Presenting With Neurocysticercosis in North America
- ClinicalTrials.gov ID
- NCT02233855
- Acronym / sponsor ID
- 140191
- Conditions
- Neurocysticercosis
- Keywords
- Seizures, Cestode, Hydrocephalus, Taenia Solium, Helminth
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 3 Sep 2014
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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
Key exclusion criteria (6 listed)
- 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-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 21912406Nash TE, Garcia HH. Diagnosis and treatment of neurocysticercosis. Nat Rev Neurol. 2011 Sep 13;7(10):584-94. doi: 10.1038/nrneurol.2011.135.
- Background: PubMed 23265551Nash 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.
- Background: PubMed 21171883Fleury 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siddhartha Mahanty, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocysticercosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233855, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.