{
  "FullStudy":{
    "Rank":218116,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512524",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2010.641"
          },
          "Organization":{
            "OrgFullName":"Hospices Civils de Lyon",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Hormonal Deficiency in the Quality of Life of Patients With Traumatic Brain Injury",
          "OfficialTitle":"Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life",
          "Acronym":"INSPIRE-TC"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2014",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2017",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2017",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"December 29, 2011",
          "StudyFirstSubmitQCDate":"January 15, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 21, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 24, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hospices Civils de Lyon",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.",
          "DetailedDescription":"Severe Traumatic Brain Injury, when not leading to mortality, is a major cause of morbidity in early adulthood.\n\nRecent studies have demonstrated a previously unappreciated association between Severe Traumatic Brain Injury and endocrine dysfunction.\n\nThe current trial aims at evaluating the quality of life 18 months post-trauma and associating this outcome to growth hormone levels."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Traumatic Brain Injury (TBI)"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Traumatic Brain Injury",
              "Quality of Life (QoL)",
              "hypopituitarism,GH"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"140",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Patients With Traumatic Brain Injury",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Study of the association between quality of life and MRI scans and endocrinology analysis (quantification of Growth Hormone) 18 months post-trauma.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: MRI scan and endocrinology analysis"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"MRI scan and endocrinology analysis",
                "InterventionDescription":"Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Patients With Traumatic Brain Injury"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "MRI scan",
                    "endocrinology analysis"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Evolution of the SF-36(Short-Form health survey)score up to 18 months post-trauma",
                "PrimaryOutcomeTimeFrame":"assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"QOLIBRI (Quality of Life after Brain Injury) measure #1",
                "SecondaryOutcomeTimeFrame":"assessed at 4 months (M4), 12 months (M12)and 18 months (M18) after brain injury."
              },{
                "SecondaryOutcomeMeasure":"Questions on Life Satisfaction-Hypopituitarism (QLS-H) measure #2",
                "SecondaryOutcomeTimeFrame":"Time frame: assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury."
              },{
                "SecondaryOutcomeMeasure":"Tests of Attentional, mnesic and executive performances #3",
                "SecondaryOutcomeDescription":"Tests of Attentional, mnesic and executive performances: - Alertness\n\nSustained Attention\nDivided Attention\nGo/NoGo\nWorking Memory\nIncompatibility\nFlexibility\nGrober and Buschke test\nRey's complex figure (copy and memory)",
                "SecondaryOutcomeTimeFrame":"assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury."
              },{
                "SecondaryOutcomeMeasure":"Functional outcomes (#4):The Glasgow Outcome Scale (GOS)-Score",
                "SecondaryOutcomeTimeFrame":"assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury."
              },{
                "SecondaryOutcomeMeasure":"Functional outcome #5 :the Functional Independence Measure (FIM)",
                "SecondaryOutcomeTimeFrame":"assessed at 4 months (M4), 12 months (M12) and 18 months (M18) after brain injury."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAll subjects must be between the ages of 18-65\nDocumented moderate to severe Traumatic Brain Injury (TBI) at less than 4 months post injury.\nGlasgow Coma Scale (GCS) equal to or greater than 12\nPatients volunteer to participate in the study, with a written informed consent signed\nBMI between 17 kg/m2 - 30kg/m2\nAffiliation to a national health insurance program\n\nExclusion Criteria:\n\nGlasgow Coma Scale (GCS) ≥13\nHistory of TBI ≥4 months\nAnterior hypopituitarism documented\nHistory of radiotherapy\nLiver dysfunction: total bilirubin <20µmol/l and/or factor V<60%)\nRenal dysfunction: creatinine clearance < 30 ml/mn (Cockcroft & Gault)\nAnyone who is currently taking or who has taken corticotherapy in the last 4 weeks before TBI\nPregnancy\nContraindications to MRI:\nPatients who have a heart pacemaker\nPatients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain\nPatients with severe claustrophobia",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Laurent Villeneuve",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+33 4 78 86 45 33",
                "CentralContactEMail":"laurent.villeneuve@chu-lyon.fr"
              },{
                "CentralContactName":"Peggy Falgon",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+33 4 78 86 45 33",
                "CentralContactEMail":"peggy.falgon@chu-lyon.fr"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Sophie Courtois, MD",
                "OverallOfficialAffiliation":"Hôpital Henry Gabrielle, Hospices Civils de Lyon",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"French University Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Lyon",
                "LocationState":"Rhône Alpes",
                "LocationZip":"69000",
                "LocationCountry":"France",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"sophie Courtois, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001930",
                "ConditionMeshTerm":"Brain Injuries"
              },{
                "ConditionMeshId":"D000070642",
                "ConditionMeshTerm":"Brain Injuries, Traumatic"
              },{
                "ConditionMeshId":"D000014947",
                "ConditionMeshTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001927",
                "ConditionAncestorTerm":"Brain Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000006259",
                "ConditionAncestorTerm":"Craniocerebral Trauma"
              },{
                "ConditionAncestorId":"D000020196",
                "ConditionAncestorTerm":"Trauma, Nervous System"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3789",
                "ConditionBrowseLeafName":"Brain Injuries",
                "ConditionBrowseLeafAsFound":"Brain Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M628",
                "ConditionBrowseLeafName":"Brain Injuries, Traumatic",
                "ConditionBrowseLeafAsFound":"Traumatic Brain Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8651",
                "ConditionBrowseLeafName":"Hypopituitarism",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafAsFound":"Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7932",
                "ConditionBrowseLeafName":"Craniocerebral Trauma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20607",
                "ConditionBrowseLeafName":"Trauma, Nervous System",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T6054",
                "ConditionBrowseLeafName":"Quality of Life",
                "ConditionBrowseLeafAsFound":"Quality of Life",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T2966",
                "ConditionBrowseLeafName":"Hypopituitarism",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}