{
  "FullStudy":{
    "Rank":217666,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518426",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011-A00102-39"
          },
          "Organization":{
            "OrgFullName":"Centre d'Investigation Clinique et Technologique 805",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population",
          "OfficialTitle":"Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population.",
          "Acronym":"3Electrods"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"June 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 22, 2011",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 5, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 6, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Centre d'Investigation Clinique et Technologique 805",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"National Research Agency, France",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to compare three different techniques of EEG recording for extraction of P300 Evoked Related Potentials (ERPs).",
          "DetailedDescription":"Brain Computer Interface (BCI) are used to restore control and communication in patient with severe disabilities such as Locked In Syndrome (LIS) patients.\n\nThe aim of this study is to identify the most relevant recording technique for extraction of P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by principal investigator."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Attitude to Computers"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Brain computer interface",
              "EEG recording",
              "Electrodes"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Early Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"10",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Extraction of P300 ERPs",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Extract P300 ERPs with Emotiv EEG headset",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: EEG Recording (Emotiv)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"EEG Recording (Emotiv)",
                "InterventionDescription":"Record EEG during auditory oddball paradigms:\n\nwith Emotiv EEG headset EMOTIV CAP (see http://www.emotiv.com)\nwith 3 electrodes : 3 different types of electrodes at the time (needle, cupule 5mm, cupule 10mm)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Extraction of P300 ERPs"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "EEG recording"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Wilcoxon statistic (Area Under the Curve)",
                "PrimaryOutcomeDescription":"An Linear Discriminant Analysis (LDA) will be used to discriminate target and Algorithm performance (Wilcoxon statistic) for discrimination between occurrent and non-occurrent stimuli.\n\nSignals will adequately be pre-processed: denoised and spatialy filtered (xDAWN). The Area Under the Receiver Operator Characteristic Curve (AUC) also called wilcoxon statistic will be used to identify the signals of best quality.",
                "PrimaryOutcomeTimeFrame":"T0+2h (end of each technique)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy volunteers male or female aging over 18\nSigned informed consent\nPassed the preliminary exam\nRegistered in the national database for persons willing to participate in Biomedical research\n\nExclusion Criteria:\n\nVisual or hearing problems\nCognitive problems\nIlliterate persons\nPersons under Guardianship or Trusteeship\nHaving Epilepsy\nPregnant women Not covered by the social security system",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Louis Mayaud, ENGINEER",
                "OverallOfficialAffiliation":"Centre d'Investigation Clinique et Technologique 805",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Raymond Poincaré Hospital",
                "LocationCity":"Garches",
                "LocationState":"Paris Area",
                "LocationZip":"92380",
                "LocationCountry":"France"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"CICIT 805 website",
                "SeeAlsoLinkURL":"http://www.cic-it.uvsq.fr/"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}