Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Average latency of taste-evoked potentials
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •Person who has given written consent
- •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
- •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
- •Fasting > 2 hours prior to PEG measurement
- •Body Mass Index (BMI) < 30 kg/m².
- •Diagnostic criteria for probable or possible LBD
排除标准
- •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
结局指标
主要结局
Average latency of taste-evoked potentials
时间窗: After a 2-hour fasting period
次要结局
未报告次要终点