- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07707219
A Study of Taste- and Olfactory-Evoked Potentials in Patients With Visual Impairment: Taste, Smell, and Vision (GOUSTAVIS)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre-Henry GABRIELLE
- Phone Number: +33 03.80.29.37.56
- Email: pierrehenry.gabrielle@chu_dijon.fr
Study Locations
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Dijon, France, 21000
- CHU Dijon Bourgogne
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Contact:
- Pierre-Henry GABRIELLE
- Phone Number: +33 03.80.29.37.56
- Email: pierrehenry.gabrielle@chu_dijon.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Healthy volunteers
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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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Other: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average latency of PEG (Taste-Evoked Potentials) peaks
Time Frame: 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
Time Frame: 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).
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At the baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GABRIELLE 2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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