NCT05320250Completed
Saliva and Extracellular Vesicles for Parkinson's Disease
Raman Spectroscopy Analysis of Saliva and Salivary Extracellular Vesicles as New Biomarkers for Parkinson's Disease and Atypical Parkinsonisms.
Source: ClinicalTrials.gov · Last updated 13 Jan 2025
Brief summary (registry, in English)
Rehabilitation is crucial in the treatment of people with Parkinson's disease (PD) as it can ameliorate motor and non-motor impairments, improving their clinical profile and quality of life. Considering the complex biological processes occurring in PD brain, the identification of accessible and measurable biomarkers to monitor the events induced by intensive rehabilitation would help in i)testing rehabilitation effectiveness, ii)improving the design of clinical trials and iii)personalizing the rehabilitation strategies by the prediction of patients' responsiveness. The objective of this project is the validation of Raman analysis of saliva and salivary extracellular vesicles (EV) for the differential diagnosis of Parkinson's disease (PD) and atypical Parkinsonism. The proposed diagnostic method can be integrated in the preliminary assessment and monitoring of the patient by providing a quickly and repeatable measurable biomarker. In the end, this will bring tothe personalization of the rehabilitation path and provide an indication on the outcome of the rehabilitation treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 165 (actual)
- First submitted
- 1 Apr 2022
- Start date
- 15 Dec 2021
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Parkinson disease
- NCT number
- NCT05320250
What you commit to
- Study type: Observational
- Participants enrolled: 165
- From 15 Dec 2021 to the primary completion date, 31 Oct 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For all the experimental groups considered and for healthy controls, subjects with concomitant chronic and / or inflammatory diseases of the oral cavity, other systemic diseases (eg anemia, cardiovascular or respiratory diseases), oncological or infectious diseases will be excluded.
Other illness
- Vascular parkinsonisms, monogenic parkinsonisms will also be excluded as well as iatrogenic parkinsonisms, parkinsonisms secondary to exposure to known neurotoxins; parkinsonisms secondary to tumor lesions; parkinsonisms due to normotensive hydrocephalus; subjects with a form of dementia, severe speech disorders and other psychiatric and / or neurological pathologies.
Who the study is looking for
- For Pakinson's disease: diagnosis following "MDS clinical diagnostic criteria for Parkinson's disease" (Postuma et al. Movement Disorders vol. 30 1591-1601, 2015), with Hoehn\&Yahr between 1 and 3.
- The diagnosis of Progressive Supranuclear Palsy will be made according to the criteria of the Movement Disorders Society (Höglinger et al. Mov. Disord. 32, 853-864, 2017). The diagnosis of Corticobasal Syndrome will be made according to the 2013 Armstrong criteria (Armstrong et al. Neurology 80, 496-503, 2013).
- The diagnosis of multiple system atrophy will be made according to the Gilman criteria of The diagnosis of Behavior Disorder in REM phase will be made according to the criteria of the "International Classification of Sleep Disorders, Third Edition (ICSD-3)".
Age in the registry: 50 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero - Universitaria di Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Unknown status |
| IRCCS Fondazione Don Carlo Gnocchi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione Don Gnocchi, Centro "S. Maria ai Servi" Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.