protocolSection identificationModule nctId: NCT06389903, orgStudyIdInfo id: 2018-A00185-50, briefTitle: Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease, acronym: PSYLES-STIM, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-06-04, primaryCompletionDateStruct date: 2020-07-03, completionDateStruct date: 2021-10-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier du Rouvray, class: OTHER_GOV, descriptionModule briefSummary: This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21)., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: assessment, outcomesModule primaryOutcomes measure: Assessment of change of mania symptoms, secondaryOutcomes measure: Assessment of change of depressive symptoms, secondaryOutcomes measure: Assessment of change of Behavior, secondaryOutcomes measure: Assessment of change of Impulsivity, secondaryOutcomes measure: Assessment of change of Apathy, secondaryOutcomes measure: Assessment of personality, secondaryOutcomes measure: Assessment of executive functions, secondaryOutcomes measure: Assessment of confusion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marie Desbordes, MD, city: Sotteville Les Rouen, zip: 76300, country: France, geoPoint lat: 49.40972, lon: 1.09005, hasResults: False