{
  "FullStudy":{
    "Rank":217557,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519843",
          "OrgStudyIdInfo":{
            "OrgStudyId":"B039201212957"
          },
          "Organization":{
            "OrgFullName":"University Hospital of Mont-Godinne",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Post Stroke Motor Learning",
          "OfficialTitle":"Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2020",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2010",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2030",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 17, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 20, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Pr Yves Vandermeeren, MD, PhD",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"University Hospital of Mont-Godinne"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University Hospital of Mont-Godinne",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning.\n\nFunctional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.",
          "DetailedDescription":"transcranial direct current stimulation will be used for NIBS"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Stroke",
              "Hemiparesis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "stroke"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"100",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Real",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Real tDCS",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: transcranial direct current stimulation tDCS",
                    "Device: transcranial magnetic stimulation TMS"
                  ]
                }
              },{
                "ArmGroupLabel":"sham",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Sham tDCS",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: transcranial direct current stimulation tDCS",
                    "Device: transcranial magnetic stimulation TMS"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"transcranial direct current stimulation tDCS",
                "InterventionDescription":"tdcs (ELDITH, Neuroconn, Ilmenau, Germany)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Real",
                    "sham"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"transcranial magnetic stimulation TMS",
                "InterventionDescription":"TMS (The Magstim Company Ltd, UK) Magstim 200² with a figure-of-eight coil was used to determine the hot spot eliciting consistent movements in the contralateral hand",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Real",
                    "sham"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Motor learning improvement with tDCS",
                "PrimaryOutcomeDescription":"performance on a motor skill learning task and on different commonly used task (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT ,...) were measured to explore the impact of tDCS on these parameters",
                "PrimaryOutcomeTimeFrame":"Improvement on motor learning were recorded from baseline to 4 weeks after the intervention"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Neuroimaging",
                "SecondaryOutcomeDescription":"Does cerebral mechanisms underlying motor learning differ from healthy subject to stroke patients?",
                "SecondaryOutcomeTimeFrame":"before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)"
              },{
                "SecondaryOutcomeMeasure":"Neurophysiological outcome measure",
                "SecondaryOutcomeDescription":"measure of brain excitability and connectivity with TMS (single and paired pulse)",
                "SecondaryOutcomeTimeFrame":"start of session 5min before motor learning, just at the end of the motor learning, after 30 min of motor learning, after 60 min of motor learning, Recall test at 1,2,3,4 weeks after the day of intervention (with or without tDCS)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nstroke with at least slight deficit\n\nExclusion Criteria:\n\nepilepsy\ncontraindication to tDCS and/or to fMRI\npresence of metal in the head\ninability to understand / complete behavioral tasks\nchronic intake of alcohol or recreational drugs\nmajor health condition\npresence of pacemaker (for the fMRI part only)\npregnancy",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"95 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Department of Neurology, CHU Mont-Godinne",
                "LocationStatus":"Recruiting",
                "LocationCity":"Yvoir",
                "LocationState":"Namur",
                "LocationCountry":"Belgium",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Yves Vandermeeren, MD,PhD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"081 42 3321",
                      "LocationContactPhoneExt":"+32",
                      "LocationContactEMail":"yves.vandermeeren@uclouvain.be"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000020521",
                "ConditionMeshTerm":"Stroke"
              },{
                "ConditionMeshId":"D000010291",
                "ConditionMeshTerm":"Paresis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000002561",
                "ConditionAncestorTerm":"Cerebrovascular Disorders"
              },{
                "ConditionAncestorId":"D000001927",
                "ConditionAncestorTerm":"Brain Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M20890",
                "ConditionBrowseLeafName":"Stroke",
                "ConditionBrowseLeafAsFound":"Stroke",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M19528",
                "ConditionBrowseLeafName":"Muscle Weakness",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11787",
                "ConditionBrowseLeafName":"Paresis",
                "ConditionBrowseLeafAsFound":"Hemiparesis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4393",
                "ConditionBrowseLeafName":"Cerebrovascular Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}