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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06439355
Acronym
PI-PEG
Enrollment
66
Registered
2024-06-03
Start date
2024-05-27
Completion date
2026-05-31
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinson's Disease and Lewy Body Disease

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.

Interventions

BIOLOGICALFasting blood test

metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays

OTHERSubject interview

socio-demographic data, medical and family history, treatment taken

MDS-UPDRS scale PART III

MoCA and MMSE scales

OTHERNutritional assessment

anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass)

Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Average latency of taste-evoked potentialsAfter a 2-hour fasting period

Countries

France

Contacts

Primary ContactVincent SCHNEIDER
vincent.schneider@chu-dijon.fr03.80.29.30.89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026