Nctid:
NCT00001366
Payload:
{"FullStudy"=>{"Rank"=>474287, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000004827", "ConditionMeshTerm"=>"Epilepsy"}, {"ConditionMeshId"=>"D000012640", "ConditionMeshTerm"=>"Seizures"}]}, "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"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M7673", "ConditionBrowseLeafName"=>"Epilepsy", "ConditionBrowseLeafAsFound"=>"Epilepsy", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M15142", "ConditionBrowseLeafName"=>"Seizures", "ConditionBrowseLeafAsFound"=>"Seizures", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M7674", "ConditionBrowseLeafName"=>"Epilepsies, Partial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4894", "ConditionBrowseLeafName"=>"Brain Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5432", "ConditionBrowseLeafName"=>"Central Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12094", "ConditionBrowseLeafName"=>"Neurologic Manifestations", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentCount"=>"230"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"August 1993"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 2002", "CompletionDateStruct"=>{"CompletionDate"=>"September 2002"}, "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"=>["Neuroimaging", "Seizures", "Cerebral Localization", "Partial Epilepsy", "Epilepsy"]}, "ConditionList"=>{"Condition"=>["Epilepsy", "Seizures"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"9109891", "ReferenceType"=>"background", "ReferenceCitation"=>"Hertz-Pannier L, Gaillard WD, Mott SH, Cuenod CA, Bookheimer SY, Weinstein S, Conry J, Papero PH, Schiff SJ, Le Bihan D, Theodore WH. Noninvasive assessment of language dominance in children and adolescents with functional MRI: a preliminary study. Neurology. 1997 Apr;48(4):1003-12. doi: 10.1212/wnl.48.4.1003."}, {"ReferencePMID"=>"9109900", "ReferenceType"=>"background", "ReferenceCitation"=>"Bookheimer SY, Zeffiro TA, Blaxton T, Malow BA, Gaillard WD, Sato S, Kufta C, Fedio P, Theodore WH. A direct comparison of PET activation and electrocortical stimulation mapping for language localization. Neurology. 1997 Apr;48(4):1056-65. doi: 10.1212/wnl.48.4.1056."}, {"ReferencePMID"=>"8598182", "ReferenceType"=>"background", "ReferenceCitation"=>"Malow BA, Blaxton TA, Sato S, Bookheimer SY, Kufta CV, Figlozzi CM, Theodore WH. Cortical stimulation elicits regional distinctions in auditory and visual naming. Epilepsia. 1996 Mar;37(3):245-52. doi: 10.1111/j.1528-1157.1996.tb00020.x."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Researchers are interested in studying if magnetic resonance imaging (MRI) is practical for locating the areas of the brain associated with language in children with epilepsy.\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\nPatients participating in the study will be asked to perform tasks designed to test language skills while undergoing an MRI to detect areas of the brain using oxygen and receiving blood flow.", "DetailedDescription"=>"We propose to study the feasibility of utilizing MRI to perform functional mapping of language cortex in children with epilepsy. We will use 1.5 Tesla MRI to study cerebral blood flow and tissue oxygenation during cognitive activation tasks derived from previous adult studies."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Children aged 5-17 years.\n\nPartial epilepsy (localized).\n\nAbility to cooperate with task paradigms (IQ greater than 65).\n\nNo cardiac pacemakers, cochlear implants, shrapnel, vascular clips, braces, or claustrophobia.\n\nNo one with inability to cooperate with task paradigms."}, "IdentificationModule"=>{"NCTId"=>"NCT00001366", "BriefTitle"=>"Mapping the Areas of the Brain Associated With Language in Children With Epilepsy", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"MRI-Based Functional Language Mapping in Children With Epilepsy", "OrgStudyIdInfo"=>{"OrgStudyId"=>"930191"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"93-N-0191"}]}}, "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"}}}}}}