{
  "FullStudy":{
    "Rank":217895,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515436",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HR11247"
          },
          "Organization":{
            "OrgFullName":"Medical University of South Carolina",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Effect of Music Periodicity on Interictal Epileptiform Discharges",
          "OfficialTitle":"A Randomized, Single-Blinded Clinical Trial: The Effect of Music Periodicity on Interictal Epileptiform Discharges"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2004"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2004",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2007",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 23, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Robert P. Turner",
            "ResponsiblePartyInvestigatorTitle":"Dr. Robert Turner",
            "ResponsiblePartyInvestigatorAffiliation":"Medical University of South Carolina"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Medical University of South Carolina",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine if having children listen to the music of Wolfgang Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike discharges on his/her Electroencephalography (EEG). These spike discharges often occur during a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike discharges after listening to Mozart's music, this information may lead to new understanding and possible treatments for epilepsy."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Rolandic Epilepsy",
              "Benign Childhood Epilepsy With Centrotemporal Spikes",
              "Epilepsy",
              "Seizures"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Rolandic Epilepsy",
              "Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS)",
              "Epilepsy",
              "Seizures",
              "Music",
              "Mozart",
              "Beethoven"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"10",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Mozart alternating with Beethoven",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Mozart alternating with Beethoven"
                  ]
                }
              },{
                "ArmGroupLabel":"Beethoven alternating with Mozart",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Beethoven alternating with Mozart"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Mozart alternating with Beethoven",
                "InterventionDescription":"Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Mozart alternating with Beethoven"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Beethoven alternating with Mozart",
                "InterventionDescription":"Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Beethoven alternating with Mozart"
                  ]
                }
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFemale or male with BCECTS clinical history, and at least one seizure, as defined by the International League Against Epilepsy.\nEEG consistent with features of BCECTS: centrotemporal (rolandic) interictal spike discharges (ISDs) with otherwise normal background interictal EEG\nScreening neurological examination normal (by PI or other pediatric neurologist in the Division of Pediatric Neurology at MUSC)\nAge 5-12 years, inclusive\nOn less than or equal to 2 anti-epileptic drugs (AED) [Range 0-2 AEDs]\n\nExclusion Criteria:\n\nCurrently taking Clonazepam or other Benzodiazepines\nInability to complete 12 hour admission and comply with study protocol\nProhibited Therapy or Activities During Study Period: Use of computer or video games. Viewing of video tapes will be prohibited due to potential effect of music in videos on underlying process of study.\nDue to the confounding factor of probably suppression of IEDs after a clinical seizure, any subject experiencing a seizure of any duration 24 hours prior to beginning the study will be excluded from the study.\nFor any subject experiencing a seizure during the study, data analysis will cease from that point onward.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"5 Years",
          "MaximumAge":"12 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Robert P Turner, MD, MSCR",
                "OverallOfficialAffiliation":"Medical University of South Carolina",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Medical University of South Carolina",
                "LocationCity":"Charleston",
                "LocationState":"South Carolina",
                "LocationZip":"29425",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000004827",
                "ConditionMeshTerm":"Epilepsy"
              },{
                "ConditionMeshId":"D000012640",
                "ConditionMeshTerm":"Seizures"
              },{
                "ConditionMeshId":"D000019305",
                "ConditionMeshTerm":"Epilepsy, Rolandic"
              }
            ]
          },
          "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":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000004828",
                "ConditionAncestorTerm":"Epilepsies, Partial"
              },{
                "ConditionAncestorId":"D000073376",
                "ConditionAncestorTerm":"Epileptic Syndromes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M6566",
                "ConditionBrowseLeafName":"Epilepsy",
                "ConditionBrowseLeafAsFound":"Epilepsy",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M19870",
                "ConditionBrowseLeafName":"Epilepsy, Rolandic",
                "ConditionBrowseLeafAsFound":"Benign Childhood Epilepsy With Centrotemporal Spikes",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14035",
                "ConditionBrowseLeafName":"Seizures",
                "ConditionBrowseLeafAsFound":"Seizures",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6567",
                "ConditionBrowseLeafName":"Epilepsies, Partial",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14938",
                "ConditionBrowseLeafName":"Syndrome",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M1165",
                "ConditionBrowseLeafName":"Epileptic Syndromes",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}