A Study of Taste- and Olfactory-Evoked Potentials in Patients With Visual Impairment: Taste, Smell, and Vision (GOUSTAVIS)
2026年7月15日 更新者：Centre Hospitalier Universitaire Dijon
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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Pierre-Henry GABRIELLE
- 电话号码：+33 03.80.29.37.56
- 邮箱：pierrehenry.gabrielle@chu_dijon.fr
学习地点
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Dijon、法国、21000
- CHU Dijon Bourgogne
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接触：
- Pierre-Henry GABRIELLE
- 电话号码：+33 03.80.29.37.56
- 邮箱：pierrehenry.gabrielle@chu_dijon.fr
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：健康志愿者
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Determination of taste and smell ability scores using standardized methods (ETOC and Taste Strips)
A recording of gustatory evoked potentials (GEP) and olfactory evoked potentials (OEP) in response to stimuli consisting of sucrose solution, vanillin, and a combination of the two.
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其他：Patients with retinal dystrophy and central or peripheral visual field defects
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Determination of taste and smell ability scores using standardized methods (ETOC and Taste Strips)
A recording of gustatory evoked potentials (GEP) and olfactory evoked potentials (OEP) in response to stimuli consisting of sucrose solution, vanillin, and a combination of the two.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Average latency of PEG (Taste-Evoked Potentials) peaks
大体时间：At the baseline
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Measurement of the mean latency of taste-evoked potential peaks in visually impaired patients versus control subjects following purely gustatory stimulation (sucrose).
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At the baseline
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Average amplitude of PEG (Taste-Evoked Potentials) peaks
大体时间：At the baseline
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Measurement of the mean amplitude of taste-evoked potential peaks in visually impaired patients versus control subjects following purely gustatory stimulation (sucrose).
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At the baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年7月2日
首先提交符合 QC 标准的
2026年7月15日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月15日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.