Natural History of Treated Neurocysticercosis and Long-Term Outcomes

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Nctid: NCT00001205

Payload: {"FullStudy"=>{"Rank"=>473710, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000020019", "ConditionMeshTerm"=>"Neurocysticercosis"}, {"ConditionMeshId"=>"D000003551", "ConditionMeshTerm"=>"Cysticercosis"}, {"ConditionMeshId"=>"D000013622", "ConditionMeshTerm"=>"Taeniasis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000020809", "ConditionAncestorTerm"=>"Central Nervous System Helminthiasis"}, {"ConditionAncestorId"=>"D000020807", "ConditionAncestorTerm"=>"Central Nervous System Parasitic Infections"}, {"ConditionAncestorId"=>"D000002494", "ConditionAncestorTerm"=>"Central Nervous System Infections"}, {"ConditionAncestorId"=>"D000007239", "ConditionAncestorTerm"=>"Infections"}, {"ConditionAncestorId"=>"D000010272", "ConditionAncestorTerm"=>"Parasitic Diseases"}, {"ConditionAncestorId"=>"D000002590", "ConditionAncestorTerm"=>"Cestode Infections"}, {"ConditionAncestorId"=>"D000006373", "ConditionAncestorTerm"=>"Helminthiasis"}, {"ConditionAncestorId"=>"D000002493", "ConditionAncestorTerm"=>"Central Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M6446", "ConditionBrowseLeafName"=>"Cysticercosis", "ConditionBrowseLeafAsFound"=>"Cysticercosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M16086", "ConditionBrowseLeafName"=>"Taeniasis", "ConditionBrowseLeafAsFound"=>"Neurocysticercosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21564", "ConditionBrowseLeafName"=>"Neurocysticercosis", "ConditionBrowseLeafAsFound"=>"Neurocysticercosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9151", "ConditionBrowseLeafName"=>"Helminthiasis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9973", "ConditionBrowseLeafName"=>"Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6058", "ConditionBrowseLeafName"=>"Communicable Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12875", "ConditionBrowseLeafName"=>"Parasitic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5433", "ConditionBrowseLeafName"=>"Central Nervous System Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5432", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1713", "ConditionBrowseLeafName"=>"Cysticercosis", "ConditionBrowseLeafAsFound"=>"Cysticercosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T2684", "ConditionBrowseLeafName"=>"Helminthiasis", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignTimePerspectiveList"=>{"DesignTimePerspective"=>["Prospective"]}, "DesignObservationalModelList"=>{"DesignObservationalModel"=>["Cohort"]}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"500"}}, "StatusModule"=>{"OverallStatus"=>"Recruiting", "StartDateStruct"=>{"StartDate"=>"October 7, 1985", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 5, 2023", "LastUpdateSubmitDate"=>"November 23, 2023", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 27, 2023", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"To characterise the radiographic, biochemical, and clinical course of neurocysticercosis during and after treatment with long term follow up, with the goal of documenting a disease free state off anthelmintics for 7 years", "PrimaryOutcomeTimeFrame"=>"7 years-indefinite", "PrimaryOutcomeDescription"=>"To study the clinical course of cysticercosis following therapy and diminish morbidity associated with treatment of cysticercosis including neurocysticercosis or the inflammation associated with therapy"}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"No", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Taenia Solium", "Neurocysticercosis", "Tapeworm", "Natural History"]}, "ConditionList"=>{"Condition"=>["Cysticercosis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"17030744", "ReferenceType"=>"background", "ReferenceCitation"=>"Nash TE, Singh G, White AC, Rajshekhar V, Loeb JA, Proano JV, Takayanagui OM, Gonzalez AE, Butman JA, DeGiorgio C, Del Brutto OH, Delgado-Escueta A, Evans CA, Gilman RH, Martinez SM, Medina MT, Pretell EJ, Teale J, Garcia HH. Treatment of neurocysticercosis: current status and future research needs. Neurology. 2006 Oct 10;67(7):1120-7. doi: 10.1212/01.wnl.0000238514.51747.3a."}, {"ReferencePMID"=>"21797658", "ReferenceType"=>"background", "ReferenceCitation"=>"Nash TE, Mahanty S, Garcia HH; Cysticercosis Group in Peru. Corticosteroid use in neurocysticercosis. Expert Rev Neurother. 2011 Aug;11(8):1175-83. doi: 10.1586/ern.11.86."}, {"ReferencePMID"=>"21912406", "ReferenceType"=>"background", "ReferenceCitation"=>"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."}, {"ReferencePMID"=>"35617367", "ReferenceType"=>"derived", "ReferenceCitation"=>"Corda M, Sciurba J, Blaha J, Mahanty S, Paredes A, Garcia HH, Nash TE, Nutman TB, O'Connell EM. A recombinant monoclonal-based Taenia antigen assay that reflects disease activity in extra-parenchymal neurocysticercosis. PLoS Negl Trop Dis. 2022 May 26;16(5):e0010442. doi: 10.1371/journal.pntd.0010442. eCollection 2022 May."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1985-I-0127.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"The purpose of this study is to evaluate, treat and follow patients with cysticercosis, an infection with the larval form of the pork tapeworm, T. solium. When people ingest cysts of T. solium eggs, cysts develop in the muscles, brain and other organs. The cysts enlarge and cause inflammation, usually in the brain. Patients may develop seizures, headache, nausea, vomiting, inability to walk, poor vision due to enlargement of the brain, and increased pressure in the brain. Other neurological problems may develop depending on the location of the cysts. The drugs praziquantel and albendazole are used to treat cysticercosis, but it is not clear if these drugs are effective in all patients, such as those with calcified cysts or brain enlargement.\n\nPatients with suspected or confirmed cysticercosis may be eligible for this study. Participants will be hospitalized for 2 to 3 weeks and will take either praziquantel or albendazole by mouth for 2 weeks. They may receive a corticosteroid to lessen the side effects of the drug therapy. Patients will be evaluated with medically indicated tests and procedures that may include:\n\nBlood tests.\nX-rays of the head and long bones.\nElectroencephalogram - recording of the electrical activity of the brain\nLumbar puncture (spinal tap) - examination of the cerebrospinal fluid that bathes the brain and spinal cord. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.\nEye examination.\nMagnetic resonance imaging (MRI) to examine the brain. MRI uses a strong magnetic field and radio waves instead of X-rays to demonstrate structural and chemical changes in the brain. During the scan, the patient lies on a table in a narrow cylinder (the scanner). He or she can speak with a staff member via an intercom system at all times during the procedure.\nComputed tomography (CT) to examine the brain. CT can be done from different angles and allows the doctor to view the brain in small sections in 3-dimensions. The patient lies on a table with the head positioned in the CT scanner.\n\nSome of the tests may be repeated on the last day of therapy and at 3 and 6 months or longer after therapy.", "DetailedDescription"=>"The purpose of this protocol is to follow participants with cysticercosis during and after completion of treatment, to characterize the disease course during both short- and long-term follow-up, assess biomarkers associated with infection and response to treatment, improve diagnostic assays, and explore host-parasite interactions. Cysticercosis is defined as an infection with the larval form of Taenia solium and includes infection of the brain (neurocysticercosis [NCC]) that accounts for most of the symptomatic disease and serious complications. Evaluation and treatment will be provided as clinically indicated. Clinical data and biospecimens will be collected during and after treatment to assess biomarkers of infection and inflammation, immunologic response to treatment, and correlations between biomarkers and results of clinically indicated diagnostic tests. In addition, we will collect information from patient-reported outcome questionnaires completed by participants to better understand the long-term effect on functional ability and determine if there is a correlation between clinical deficits with biomarkers of inflammation."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"99 years", "MinimumAge"=>"3 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "SamplingMethod"=>"Probability Sample", "StudyPopulation"=>"Male and female subjects aged 3-99 years with likely or definite neurocysticercosis (NCC) diagnosis", "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nPatients ages 3 to 99 years.\nPatients with proven or likely neurocysticercosis.\nWillingness (of participant or legally authorized representative [LAR]) to sign consent and comply with study requirements.\n\nEXCLUSION CRITERIA:\n\nNot applicable."}, "IdentificationModule"=>{"NCTId"=>"NCT00001205", "BriefTitle"=>"Natural History of Treated Neurocysticercosis and Long-Term Outcomes", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Natural History of Treated Neurocysticercosis and Long-Term Outcomes", "OrgStudyIdInfo"=>{"OrgStudyId"=>"850127"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"85-I-0127"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupLabel"=>"1", "ArmGroupDescription"=>"Male and female subjects aged 3-75 years with likely or definite neurocysticercosis (NCC) diagnosis"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationStatus"=>"Recruiting", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center"}]}, "CentralContactList"=>{"CentralContact"=>[{"CentralContactName"=>"JeanAnne M Ware, C.R.N.P.", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"warejm@niaid.nih.gov", "CentralContactPhone"=>"(301) 594-3149"}, {"CentralContactName"=>"Elise M O'Connell, M.D.", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"oconnellem@mail.nih.gov", "CentralContactPhone"=>"(301) 761-5413"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Elise M O'Connell, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}