A Study of Taste- and Olfactory-Evoked Potentials in Patients With Visual Impairment: Taste, Smell, and Vision
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Average latency of PEG (Taste-Evoked Potentials) peaks
研究概览
简要总结
Visual impairment, whether central or peripheral, may influence the plasticity of other sensory modalities, such as taste and smell. Taste-evoked potentials (TEPs) and smell-evoked potentials (SEPs)-methods for analyzing brain activity in response to taste and smell stimuli-allow for the objective assessment of these interactions. This approach has already demonstrated its value in the study of cognitive disorders. This study aims to demonstrate an enhancement of taste and smell capabilities that could compensate for specific visual impairments, particularly in situations involving food choices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult: ≥ 18 years and ≤ 60 years
- •Individual who has given oral consent
- •Individual who has been fasting (no food, drink, or tobacco) for at least 1 hour prior to PEG and PEO measurement
- •No cognitive complaints and normal neurological examination.
- •Group of patients with visual impairment:
- •A. Central: documented bilateral macular dystrophy (e.g., Stargardt disease, Best disease) with confirmed central scotoma (CV 24.2, 10.2, or 30.2).
- •B. Peripheral: documented bilateral peripheral retinal dystrophy with confirmed peripheral involvement (CV 30-2 or 24-2).
- •Control group: a person with normal vision and no known ophthalmological abnormalities (normal visual acuity and fundus examination) who is precisely matched by sex and smoking status (former smoker who has quit vs. nonsmoker), and approximately matched by age (± 5 years) to a visually impaired participant included in the study.
排除标准
- •For this group: patients with visual impairments:
- •Individuals who are not enrolled in or eligible for a social security program
- •Individuals subject to a legal protective measure (guardianship, conservatorship)
- •Individuals subject to judicial safeguard measures
- •Adults who are legally incapacitated or unable to give informed consent
- •Documented COVID-19 infection within the 6 months prior to enrollment
- •Active smokers (≥1 cigarette per day) or users of any other inhaled substances (water pipe, cannabis, etc.)
- •Participants following a sugar-free diet
- •Participants with diabetes, of any type
- •Participants taking medication (ongoing during the study) that interferes with taste perception • Pregnant or breastfeeding women
- •Individuals with neurodegenerative diseases (Parkinson's, Alzheimer's)
- •Individuals with braids, dreadlocks, or any other hairstyle that prevents electrodes from being placed in sufficiently precise locations on the scalp.
- •Overweight subjects with a BMI ≥ 35 kg/m²
结局指标
主要结局
Average latency of PEG (Taste-Evoked Potentials) peaks
时间窗: At the baseline
Measurement of the mean latency of taste-evoked potential peaks in visually impaired patients versus control subjects following purely gustatory stimulation (sucrose).
Average amplitude of PEG (Taste-Evoked Potentials) peaks
时间窗: At the baseline
Measurement of the mean amplitude of taste-evoked potential peaks in visually impaired patients versus control subjects following purely gustatory stimulation (sucrose).
次要结局
未报告次要终点