NCT06439355 Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis
| NCT ID | NCT06439355 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Idiopathic Parkinson's Disease and Lewy Body Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-05-27 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2024-05-27 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06439355 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Idiopathic Parkinson's Disease and Lewy Body Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06439355 currently recruiting?
Yes, NCT06439355 is actively recruiting participants. Contact the research team at vincent.schneider@chu-dijon.fr for enrollment information.
Where is the NCT06439355 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT06439355 clinical trial?
NCT06439355 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 66 participants.
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