Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis (PI-PEG)

University Hospital Center (CHU) Dijon Bourgogne

Status: Enrolling

Conditions: Idiopathic Parkinson's Disease and Lewy Body Disease

Treatments: Other: Nutritional assessment; Other: Neurocognitive assessment; Other: Subject interview; Other: Motor assessment; Other: Taste tests; Biological: Fasting blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT06439355

SCHNEIDER J'InvEST-I 2023

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Healthy volunteers

Active Comparator group

Treatment:

Other: Taste tests

Biological: Fasting blood test

Other: Motor assessment

Other: Subject interview

Other: Neurocognitive assessment

Other: Nutritional assessment

Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years

Experimental group

Treatment:

Other: Taste tests

Biological: Fasting blood test

Other: Motor assessment

Other: Subject interview

Other: Neurocognitive assessment

Other: Nutritional assessment

Patients with Lewy body disease (LBD) progressing ≤ 3 years

Experimental group

Treatment:

Other: Taste tests

Biological: Fasting blood test

Other: Motor assessment

Other: Subject interview

Other: Neurocognitive assessment

Other: Nutritional assessment