Nctid:
NCT00001325
Payload:
{"FullStudy"=>{"Rank"=>473114, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000004827", "ConditionMeshTerm"=>"Epilepsy"}, {"ConditionMeshId"=>"D000012640", "ConditionMeshTerm"=>"Seizures"}, {"ConditionMeshId"=>"D000004828", "ConditionMeshTerm"=>"Epilepsies, Partial"}, {"ConditionMeshId"=>"D000013036", "ConditionMeshTerm"=>"Spasms, Infantile"}, {"ConditionMeshId"=>"D000004829", "ConditionMeshTerm"=>"Epilepsy, Generalized"}, {"ConditionMeshId"=>"D000008659", "ConditionMeshTerm"=>"Metabolic Diseases"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001927", "ConditionAncestorTerm"=>"Brain Diseases"}, {"ConditionAncestorId"=>"D000002493", "ConditionAncestorTerm"=>"Central Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009461", "ConditionAncestorTerm"=>"Neurologic Manifestations"}, {"ConditionAncestorId"=>"D000073376", "ConditionAncestorTerm"=>"Epileptic Syndromes"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15142", "ConditionBrowseLeafName"=>"Seizures", "ConditionBrowseLeafAsFound"=>"Seizures", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M11329", "ConditionBrowseLeafName"=>"Metabolic Diseases", "ConditionBrowseLeafAsFound"=>"Metabolic Diseases", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M7673", "ConditionBrowseLeafName"=>"Epilepsy", "ConditionBrowseLeafAsFound"=>"Epilepsy", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12", "ConditionBrowseLeafName"=>"Congenital Abnormalities", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7674", "ConditionBrowseLeafName"=>"Epilepsies, Partial", "ConditionBrowseLeafAsFound"=>"Partial Epilepsy", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M30283", "ConditionBrowseLeafName"=>"Lennox Gastaut Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11767", "ConditionBrowseLeafName"=>"Muscle Cramp", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15527", "ConditionBrowseLeafName"=>"Spasm", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15528", "ConditionBrowseLeafName"=>"Spasms, Infantile", "ConditionBrowseLeafAsFound"=>"Infantile Spasms", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M7675", "ConditionBrowseLeafName"=>"Epilepsy, Generalized", "ConditionBrowseLeafAsFound"=>"Generalized Epilepsy", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4894", "ConditionBrowseLeafName"=>"Brain Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5432", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12094", "ConditionBrowseLeafName"=>"Neurologic Manifestations", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M1165", "ConditionBrowseLeafName"=>"Epileptic Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3371", "ConditionBrowseLeafName"=>"Lennox-Gastaut Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5916", "ConditionBrowseLeafName"=>"West Syndrome", "ConditionBrowseLeafAsFound"=>"Infantile Spasms", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Nutritional and Metabolic Diseases", "ConditionBrowseBranchAbbrev"=>"BC18"}, {"ConditionBrowseBranchName"=>"Diseases and Abnormalities at or Before Birth", "ConditionBrowseBranchAbbrev"=>"BC16"}, {"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000019788", "InterventionMeshTerm"=>"Fluorodeoxyglucose F18"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000019275", "InterventionAncestorTerm"=>"Radiopharmaceuticals"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M21376", "InterventionBrowseLeafName"=>"Fluorodeoxyglucose F18", "InterventionBrowseLeafAsFound"=>"Self-monitoring", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M20948", "InterventionBrowseLeafName"=>"Radiopharmaceuticals", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentCount"=>"80"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"April 1992"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 2004", "CompletionDateStruct"=>{"CompletionDate"=>"June 2004"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Positron", "Tomography", "Seizures", "Epileptic Focus", "Electroencephalography", "Metabolism", "Glucose", "Cerebral", "Positron Emission Tomography", "Lennox Gastaut Syndrome"]}, "ConditionList"=>{"Condition"=>["Generalized Epilepsy", "Infantile Spasms", "Metabolic Disease", "Partial Epilepsy", "Seizures"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"6416142", "ReferenceType"=>"background", "ReferenceCitation"=>"Bourgeois BF, Prensky AL, Palkes HS, Talent BK, Busch SG. Intelligence in epilepsy: a prospective study in children. Ann Neurol. 1983 Oct;14(4):438-44. doi: 10.1002/ana.410140407."}, {"ReferencePMID"=>"3501693", "ReferenceType"=>"background", "ReferenceCitation"=>"Chugani HT, Phelps ME, Mazziotta JC. Positron emission tomography study of human brain functional development. Ann Neurol. 1987 Oct;22(4):487-97. doi: 10.1002/ana.410220408."}, {"ReferencePMID"=>"6818896", "ReferenceType"=>"background", "ReferenceCitation"=>"Engel J Jr, Kuhl DE, Phelps ME, Mazziotta JC. Interictal cerebral glucose metabolism in partial epilepsy and its relation to EEG changes. Ann Neurol. 1982 Dec;12(6):510-7. doi: 10.1002/ana.410120603."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study is designed to use positron emission tomography to measure brain energy use. Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.\n\nWhen a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also.\n\nResearchers can label a sugar with a small radioactive molecule called FDG (fluorodeoxyglucose). As areas of the brain use more sugar the PET scan will detect the FDG and show the areas of the brain that are active. By using this technique researchers hope to answer the following questions;\n\n4. Are changes in brain energy use (metabolism) present early in the course of epilepsy\n\n5. Do changes in brain metabolism match the severity of patient's seizures\n\n6. Do changes in metabolism occur over time or in response to drug therapy", "DetailedDescription"=>"We propose to study children with recent onset partial epilepsy, cryptogenic infantile spasms, and idiopathic Lennox-Gastaut Syndrome with serial FDG-PET to elucidate the natural history and evolution of metabolic abnormalities associated with such epilepsies. The severity of the seizure disorder, and cognitive impairment, when present, will be correlated with the presence and extent of focal and global cerebral metabolic abnormalities."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nPatients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected.\n\nEXCLUSION CRITERIA:\n\nEvidence of a structural lesion as cause for epilepsy.\n\nDegenerative or metabolic disease.\n\nInability to comply with the protocol."}, "IdentificationModule"=>{"NCTId"=>"NCT00001325", "BriefTitle"=>"Metabolic Abnormalities in Children With Epilepsy", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Natural History of Metabolic Abnormalities in Children With Epilepsy", "OrgStudyIdInfo"=>{"OrgStudyId"=>"920175"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"92-N-0175"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"18 FDG", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institute of Neurological Disorders and Stroke (NINDS)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "LeadSponsorClass"=>"NIH"}}}}}}
