{
  "FullStudy":{
    "Rank":218134,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512290",
          "OrgStudyIdInfo":{
            "OrgStudyId":"UMCU_TBS"
          },
          "Organization":{
            "OrgFullName":"UMC Utrecht",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations",
          "OfficialTitle":"Theta Burst Transcranial Magnetic Stimulation as Treatment for Auditory Verbal Hallucinations; a Placebo-controlled Trail"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 24, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 25, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Iris Sommer",
            "ResponsiblePartyInvestigatorTitle":"Principle Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"UMC Utrecht"
          },
          "LeadSponsor":{
            "LeadSponsorName":"UMC Utrecht",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Auditory verbal hallucinations (AVH) are a characterising symptom of schizophrenia. In the majority of patients, these AVH respond well to antipsychotic medication. Yet, a significant minority continues to experience frequent AVH despite optimal pharmacotherapy. The number of alternative treatment options for this medication resistant group is currently low and most of them focus on coping with the hallucinations. Transcranial magnetic stimulation (TMS), in contrast, is a non-invasive technique of influencing cortical excitability. This technique has the potential to actually decrease the frequency and severity of medication resistant hallucinations.\n\nSeveral previous studies have assessed efficacy of low frequency rTMS, with contradicting results. A previous large study by the investigators group could not demonstrate efficacy of low frequency rTMS. A new stimulation protocol using theta burst rTMS (TBS) could provide a more effective therapeutic option.\n\nObjective: The present study aims to examine the efficacy of TBS on the severity of AVH. Study design: The objectives are tested in a randomized double blind placebo-controlled trail.\n\nStudy population: 60 patients with the diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal hallucinations will be included.\n\nIntervention: The participant will receive either 10 TBS treatments or 10 placebo treatments consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area, distributed over 5 treatment days. Stimulation will be at 80% of the motor threshold.\n\nMain study parameters/endpoints: the main study parameter is the change in the severity of the AVH. The secondary study parameter is the number and severity of adverse events."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Schizophrenia",
              "Psychotic Disorders"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Auditory verbal hallucinations",
              "Transcranial Magnetic stimulation",
              "Theta Burst frequency"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"71",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Theta burst treatment",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"patients randomized to this arm will receive 10 TBS treatments distributed over 5 days",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Theta Burst Transcranial Magnetic Stimulation"
                  ]
                }
              },{
                "ArmGroupLabel":"sham treatment",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Theta Burst Transcranial Magnetic Stimulation"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Theta Burst Transcranial Magnetic Stimulation",
                "InterventionDescription":"This rTMS paradigm consists of 5 pulses at 50Hz repeated at 5Hz for 60 seconds with a total of 900 pulses per treatment",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Theta burst treatment",
                    "sham treatment"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in severity and frequency of auditory verbal hallucinations",
                "PrimaryOutcomeDescription":"This is as experienced by the participant. The change in score on the Auditory Hallucination Assessment Scale (AHAS; Frederick, 2000), the PSYRATS (Haddock et al., 1999) and the total score on the PANSS item 3 (Kay et al. 1987), the item concerning the severity of the hallucinations, after one week of treatment end one month after treatment will be used for this outcome.",
                "PrimaryOutcomeTimeFrame":"1 week/ 1 month"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number and severity of adverse events",
                "SecondaryOutcomeDescription":"This is measured by the use of a selection of the Global index of Safety (Prieto, Sacristan & Gomez, 2004). The scores on this questionnaire are compared between the two conditions.",
                "SecondaryOutcomeTimeFrame":"1 week/ 1 month"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified.\nAge 18+ years.\nFrequent auditory verbal hallucinations (cut-off at >once an hour).\nWritten informed consent.\n\nExclusion Criteria:\n\nMetal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing, cardiac pacemaker, medicinal pumps)\nHistory of seizures\nIncreased intracranial pressure due to infarcts or trauma.\nHistory of eye trauma with a metal object or professional metal workers\nPatients who are coercively treated at a psychiatric ward (based on a judicial ruling)\nPatients who are represented by a legal ward or under legal custody\nIn female patients, there should be no possibility for pregnancy as determined with a pregnancy test\nChanges in the prescribed medication in a period of 2 weeks prior to participation",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Iris Sommer, Prof., Dr.",
                "OverallOfficialAffiliation":"UMC Utrecht",
                "OverallOfficialRole":"Study Director"
              },{
                "OverallOfficialName":"Anne Lotte Meijering, MSc.",
                "OverallOfficialAffiliation":"UMC Utrecht",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"UMC Utrecht",
                "LocationCity":"Utrecht",
                "LocationZip":"3584 CX",
                "LocationCountry":"Netherlands"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006212",
                "ConditionMeshTerm":"Hallucinations"
              },{
                "ConditionMeshId":"D000012559",
                "ConditionMeshTerm":"Schizophrenia"
              },{
                "ConditionMeshId":"D000001523",
                "ConditionMeshTerm":"Mental Disorders"
              },{
                "ConditionMeshId":"D000011618",
                "ConditionMeshTerm":"Psychotic Disorders"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000019967",
                "ConditionAncestorTerm":"Schizophrenia Spectrum and Other Psychotic Disorders"
              },{
                "ConditionAncestorId":"D000010468",
                "ConditionAncestorTerm":"Perceptual Disorders"
              },{
                "ConditionAncestorId":"D000019954",
                "ConditionAncestorTerm":"Neurobehavioral Manifestations"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafAsFound":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7887",
                "ConditionBrowseLeafName":"Hallucinations",
                "ConditionBrowseLeafAsFound":"Hallucinations",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13959",
                "ConditionBrowseLeafName":"Schizophrenia",
                "ConditionBrowseLeafAsFound":"Schizophrenia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafAsFound":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20422",
                "ConditionBrowseLeafName":"Schizophrenia Spectrum and Other Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11962",
                "ConditionBrowseLeafName":"Perceptual Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20410",
                "ConditionBrowseLeafName":"Neurobehavioral Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}