{
  "FullStudy":{
    "Rank":218146,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512134",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011H0329"
          },
          "Organization":{
            "OrgFullName":"Ohio State University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Deep Brain Stimulation for the Treatment of Obesity",
          "OfficialTitle":"Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 28, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 30, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Ali Rezai, MD",
            "ResponsiblePartyInvestigatorTitle":"Professor of Neurological Surgery",
            "ResponsiblePartyInvestigatorAffiliation":"Ohio State University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Ali Rezai, MD",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option for obesity.",
          "DetailedDescription":"The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option in the management of severe, treatment refractory, morbid obesity."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Obesity"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Obesity",
              "DBS"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Device Feasibility",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"3",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"DBS Surgery",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"All patients enrolled will undergo DBS implantation in the targeted region to assess the safety of the procedure and the efficacy through weight loss.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Deep Brain Stimulation Device"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Deep Brain Stimulation Device",
                "InterventionDescription":"Deep brain stimulation surgery",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "DBS Surgery"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Reclaim"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Percentage of excess weight loss",
                "PrimaryOutcomeDescription":"The primary outcome measure at the conclusion of the study will be percent of excess weight loss (EWL).",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAt least 24 months post Roux-en-Y gastric bypass surgery without evidence of a sustained improvement in BMI after gastric bypass surgery for at least 6 months.\nParticipant is willing to comply with all follow-up evaluations at the specified times\nParticipant is able to provide informed consent\nFluent in English\n\nExclusion Criteria:\n\nMedical contraindications for general anesthesia, craniotomy, or DBS surgery\nEvidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.\nSevere cardiovascular, pulmonary, renal, liver, hematological disease, severe coagulopathy, acute infectious process",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"22 Years",
          "MaximumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Ali Rezai, MD",
                "OverallOfficialAffiliation":"Ohio State University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"The Ohio State University Medical Center",
                "LocationCity":"Columbus",
                "LocationState":"Ohio",
                "LocationZip":"43210",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"32140113",
                "ReferenceType":"derived",
                "ReferenceCitation":"Weichart ER, Sederberg PB, Sammartino F, Krishna V, Corrigan JD, Rezai AR. Cognitive Task Performance During Titration Predicts Deep Brain Stimulation Treatment Efficacy: Evidence From a Case Study. Front Psychiatry. 2020 Feb 19;11:30. doi: 10.3389/fpsyt.2020.00030. eCollection 2020."
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"No"
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009765",
                "ConditionMeshTerm":"Obesity"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000044343",
                "ConditionAncestorTerm":"Overnutrition"
              },{
                "ConditionAncestorId":"D000009748",
                "ConditionAncestorTerm":"Nutrition Disorders"
              },{
                "ConditionAncestorId":"D000050177",
                "ConditionAncestorTerm":"Overweight"
              },{
                "ConditionAncestorId":"D000001835",
                "ConditionAncestorTerm":"Body Weight"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11284",
                "ConditionBrowseLeafName":"Obesity",
                "ConditionBrowseLeafAsFound":"Obesity",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M23894",
                "ConditionBrowseLeafName":"Overnutrition",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11267",
                "ConditionBrowseLeafName":"Nutrition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}