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NCT06439355
Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis
Conditions: Idiopathic Parkinson's Disease and Lewy Body Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 66
Sponsor: Centre Hospitalier Universitaire Dijon
Location: Chu Dijon Bourgogne Dijon
Summary
The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants:
* healthy volunteers
* patients with early Parkinson's disease
* patients with incipient Lewy body disease.
To 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.
This 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.
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers:
* Person who has given written consent
* Adult
* Enrolled in the national register of healthy volunteers
* Fasting \> 2 hours before PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* No cognitive complaints and normal neurological assessment
Patients with idiopathic Parkinson's disease:
* Person who has given written consent
* Adult
* Fasting \> 2 hours before PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* Diagnostic criteria for established or probable IPD
Patients with Lewy body disease:
* Person who has given written consent
* Adult
* Fasting \> 2 hours prior to PEG measurement
* Body Mass Index (BMI) \< 30 kg/m².
* Diagnostic criteria for probable or possible LBD
Exclusion Criteria:
* Non-affiliated to national health insurance
* Person under legal protection (curatorship, guardianship)
* Person subject to a court order
* Pregnant, parturient or breast-feeding women
* Major unable to give consent
* MMSE score \< 15 and/or MoCA \< 10
* Known infection with COVID-19 in the 6 months prior to inclusion
* Active smoker (\> 4 cigarettes per day on a regular basis)
* Subject with pacemaker (contraindication for bioelectrical impedancemetry)
* Diabetic (type 1 or type 2)
* Taking medication (in progress at the time of the study) that interferes with gustation
Source: ClinicalTrials.gov (NCT06439355). StuddyBuddy aggregates publicly available trial information.