[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549845":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":18,"interventions":36,"overallOfficials":11,"centralContacts":62,"locations":68,"responsibleParty":83,"collaborators":11,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":11,"enrollmentInfo":95,"targetDuration":11,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":11,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Dijon","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Average latency of taste-evoked potentials",null,"After a 2-hour fasting period",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":6,"observationalModel":11,"timePerspective":11,"maskingInfo":16},"NON_RANDOMIZED","PARALLEL",{"masking":17,"maskingDescription":11,"whoMasked":11},"NONE",[19,29,33],{"label":20,"type":21,"description":11,"interventionNames":22},"Healthy volunteers","ACTIVE_COMPARATOR",[23,24,25,26,27,28],"Biological: Fasting blood test","Other: Subject interview","Other: Motor assessment","Other: Neurocognitive assessment","Other: Nutritional assessment","Other: Taste tests",{"label":30,"type":31,"description":11,"interventionNames":32},"Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years","EXPERIMENTAL",[23,24,25,26,27,28],{"label":34,"type":31,"description":11,"interventionNames":35},"Patients with Lewy body disease (LBD) progressing ≤ 3 years",[23,24,25,26,27,28],[37,42,46,50,54,58],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"BIOLOGICAL","Fasting blood test","metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays",[20,30,34],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":11},"Subject interview","socio-demographic data, medical and family history, treatment taken",[20,30,34],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":11},"Motor assessment","MDS-UPDRS scale PART III",[20,30,34],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"Neurocognitive assessment","MoCA and MMSE scales",[20,30,34],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"Nutritional assessment","anthropometric data (weight, height, BMI, waist circumference, hip circumference, android\u002Fgynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass)",[20,30,34],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"Taste tests","Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)",[20,30,34],[63],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Vincent SCHNEIDER","CONTACT","03.80.29.30.89","vincent.schneider@chu-dijon.fr",[69],{"facility":70,"status":71,"city":72,"state":11,"zip":11,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Chu Dijon Bourgogne","RECRUITING","Dijon","France","FR",{"type":76,"coordinates":77},"Point",[78,79],5.01391,47.31344,{"lat":79,"lon":78},[82],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},{"type":84,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100549845","single-center-study-of-gustation-in-idiopathic-parkinsons-disease-and-lewy-body-disease-using-gustatory-evoked-potential-analysis-100549845",false,"NCT06439355","Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis","PI-PEG","Inclusion Criteria:\n\nHealthy volunteers:\n\n* Person who has given written consent\n* Adult\n* Enrolled in the national register of healthy volunteers\n* Fasting \\> 2 hours before PEG measurement\n* Body Mass Index (BMI) \\\u003C 30 kg\u002Fm².\n* No cognitive complaints and normal neurological assessment\n\nPatients with idiopathic Parkinson's disease:\n\n* Person who has given written consent\n* Adult\n* Fasting \\> 2 hours before PEG measurement\n* Body Mass Index (BMI) \\\u003C 30 kg\u002Fm².\n* Diagnostic criteria for established or probable IPD\n\nPatients with Lewy body disease:\n\n* Person who has given written consent\n* Adult\n* Fasting \\> 2 hours prior to PEG measurement\n* Body Mass Index (BMI) \\\u003C 30 kg\u002Fm².\n* Diagnostic criteria for probable or possible LBD\n\nExclusion Criteria:\n\n* Non-affiliated to national health insurance\n* Person under legal protection (curatorship, guardianship)\n* Person subject to a court order\n* Pregnant, parturient or breast-feeding women\n* Major unable to give consent\n* MMSE score \\\u003C 15 and\u002For MoCA \\\u003C 10\n* Known infection with COVID-19 in the 6 months prior to inclusion\n* Active smoker (\\> 4 cigarettes per day on a regular basis)\n* Subject with pacemaker (contraindication for bioelectrical impedancemetry)\n* Diabetic (type 1 or type 2)\n* Taking medication (in progress at the time of the study) that interferes with gustation",true,"ALL","18 Years",{"count":96,"type":97},66,"ESTIMATED","INTERVENTIONAL",[100],"NA","The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants:\n\n* healthy volunteers\n* patients with early Parkinson's disease\n* patients with incipient Lewy body disease.\n\nTo this end, the results obtained from taste evoked potentials in each of the 3 groups of participants will be compared with each other and with different nutritional, motor and cognitive data.\n\nThis study could reveal a difference in cortical processing of gustatory sensory information between patients who have had idiopathic Parkinson's disease progressing for 3 years or less, and patients who have had Lewy body disease progressing for 3 years or less. Indeed, a modification of taste evoked potentials (in terms of latencies) proportional to the degree of cerebral degeneration could be observed.",[103],"Idiopathic Parkinson's Disease and Lewy Body Disease","2026-10-06",{"date":106,"type":107},"2026-10-07","ACTUAL",{"date":109,"type":107},"2024-05-27",{"date":111,"type":97},"2027-05",{"name":5,"class":6},1]