{
  "FullStudy":{
    "Rank":218147,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512121",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011H0040"
          },
          "Organization":{
            "OrgFullName":"Ohio State University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Spinal Cord Stimulation and Functional MRI",
          "OfficialTitle":"Investigating the Cortical Correlates of Spinal Cord Stimulation Using Functional Magnetic Resonance Imaging"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2017",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2017",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 20, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 23, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Vibhor Krishna",
            "ResponsiblePartyInvestigatorTitle":"Assistant Professor of Neurological Surgery",
            "ResponsiblePartyInvestigatorAffiliation":"Ohio State University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Vibhor Krishna",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Medtronic",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The overall objective of this study is to assess patterns of fMRI cortical activation with spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define cortical correlates, as well as to investigate cortical representations of pain and pain relief and the interactions therein, in the setting of neuropathic leg pain and SCS.",
          "DetailedDescription":"The main objective is to define, using functional magnetic resonance imaging, the effects of spinal cord stimulation (SCS) on cortical and subcortical BOLD effects in patients with neuropathic leg pain. Our hypothesis is that SCS will demonstrate a consistent pattern of BOLD activation that will correlate with symptomatic improvement."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Complex Regional Pain Syndrome (CRPS)",
              "Neuropathic Leg Pain"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Other"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"10",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"functional MRI testing",
                "ArmGroupDescription":"fMRI scanning with SCS \"on\" and \"off\" at different settings."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Effects of spinal cord stimulation on patients with neuropathic leg pain through fMRI analysis",
                "PrimaryOutcomeDescription":"We are analyzing the data from fMRI scans to understand more the functional activation of the cerebral cortex",
                "PrimaryOutcomeTimeFrame":"1 year"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge 18-55 years at time of enrollment.\nHave previous implantation of thoracic epidural Medtronic Restore Ultra, Prime Advanced and Restore Advanced SCS in place for the treatment of CPRS-type 1 or chronic refractory neuropathic leg pain following FBSS. The implantation must be 3 or more months prior to enrollment.\nPatient must have reported significant pain improvement (>50%) following implantation of the SCS.\nHave consistently reproducible pain relief (> 50%) within 10 minutes of switching SCS from an OFF state to an ON state (with \"optimal\" parameters - see below).\nThe SCS battery is implanted in the buttocks region.\nUnilateral or bilateral extremity pain.\nAble to provide informed consent.\n\nExclusion Criteria:\n\n- Contraindication to MRI such as: SCS lead in the cervical epidural region Cardiac pacemaker Intracranial aneurysm clips, metallic implants or external clips within 10mm of the head Metallic foreign metals within the orbits Pregnancy; (urine pregnancy test will be done to confirm) Claustrophobia\n\nPattern of response to spinal cord stimulation Inconsistent response of pain to spinal cord stimulation Long interval (> 10 minutes) before pain relief following switching SCS from an OFF state to an ON state (with \"optimal\" parameters) - long \"washout\" period Lack of significant pain improvement (< 50%) following implantation of SCS\nPositive history of significant brain lesions or pathology including:\nPrior ablative neurosurgery\nHistory of large vessel strokes or brain tumors\nPsychological Screening",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          },
          "StudyPopulation":"Patients with implanted spinal cord stimulators",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Vibhor Krishna, MD",
                "OverallOfficialAffiliation":"Ohio State University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"The Ohio State Medical Center",
                "LocationCity":"Columbus",
                "LocationState":"Ohio",
                "LocationZip":"43210",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000020918",
                "ConditionMeshTerm":"Complex Regional Pain Syndromes"
              },{
                "ConditionMeshId":"D000012019",
                "ConditionMeshTerm":"Reflex Sympathetic Dystrophy"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001342",
                "ConditionAncestorTerm":"Autonomic Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000010523",
                "ConditionAncestorTerm":"Peripheral Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009468",
                "ConditionAncestorTerm":"Neuromuscular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14938",
                "ConditionBrowseLeafName":"Syndrome",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21237",
                "ConditionBrowseLeafName":"Complex Regional Pain Syndromes",
                "ConditionBrowseLeafAsFound":"Complex Regional Pain Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13444",
                "ConditionBrowseLeafName":"Reflex Sympathetic Dystrophy",
                "ConditionBrowseLeafAsFound":"Complex Regional Pain Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M26566",
                "ConditionBrowseLeafName":"Primary Dysautonomias",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3224",
                "ConditionBrowseLeafName":"Autonomic Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12015",
                "ConditionBrowseLeafName":"Peripheral Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10994",
                "ConditionBrowseLeafName":"Neuromuscular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T1447",
                "ConditionBrowseLeafName":"Complex Regional Pain Syndrome",
                "ConditionBrowseLeafAsFound":"Complex Regional Pain Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}