Saliva and Extracellular Vesicles for Parkinson's Disease

NCT05320250 | Completed

• 1 other identifier: FDG_Saliva_Parkinson_RaSPiD
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Parkinson's Disease and Parkinsonism

Keywords

saliva; Raman spectroscopy; extracellular vesicles; rehabilitation biomarkers; diagnosis

Outcome Measures

Primary Outcomes (1)

• Salivary Raman fingerprint of PD and atypical parkinsonism

  Differences in the Raman spectra of saliva. Raman spectroscopy analysis of the saliva of patients with PD and atypical Parkinsonisms for the validation of the diagnostic power of the method

  15/12/2021 - 30/11/2024

Secondary Outcomes (3)

• Salivary Raman fingerprint of PD patients after rehabilitation

  15/12/2021 - 30/11/2024

• Salivary Extracellular vesicles characterization

  01/03/2022 - 30/11/2024

• Correlation of Raman data with clinical assessments

  01/10/2022 - 31/12/2024

Study Arms (4)

Parkinson's disease

60 patients. People with Parkinson's disease (pwPD) will be recruited for the study at Fondazione Don Gnocchi. PwPD will be assigned to a rehabilitation program that will last for 6 consecutive weeks. Two possible rehabilitation plans are included: 1. Rehabilitation treatment at the IRCCS S. Maria Nascente: 30 sessions / 5 days a week including motor rehabilitation, cognitive rehabilitation and speech therapy rehabilitation. 2. Self-treatment program consisting of stretching and active mobilization exercises at home. Before starting the program, the subjects will undergo an educational and training session with the physiotherapist to learn the correct way of carrying out the proposed exercises.

Other: Saliva collection, longitudinal

Atypical Parkinsonism

Progressive supranuclear palsy: 20 patients; Corticobasal syndrome: 20 patients; Multisystemic atrophy: 20 patients.

Other: Single saliva collection

REM sleep Behavior Disorder

30 patients

Other: Single saliva collection

Healthy controls

30 patients

Other: Single saliva collection

Interventions

Single saliva collection OTHER

1 ml of saliva will be collected with Salivette swabs.

Atypical Parkinsonism; Healthy controls; REM sleep Behavior Disorder

Saliva collection, longitudinal OTHER

1 ml of saliva will be collected with Salivette swabs. Subjects diagnosed with PD will undergo assessments and saliva sampling before starting rehabilitation treatment (T0), at the end of treatment (T1) and 3 months after the end of treatment (T2).

Parkinson's disease

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PD patients and people with atypical Parkinsonism will be recrutied at the Neurology Rehabilitation Unit of IRCCS S. Maria Nascente of Fondazione Don Gnocchi, before and after the rehabilitation treatment, at IRCCS Don Gnocchi (Florence) and Centro "S. Maria ai Servi" (Parma). Subjects with RBD will be recruited at the University of Cagliari - Neurology Complex Operating Unit - Sleep Center.

You may qualify if:

• 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)".

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Azienda Ospedaliero Universitaria di Cagliari: collaborator

Study Sites (4)

Azienda Ospedaliero - Universitaria di Cagliari

Cagliari, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi

Florence, 50100, Italy

Location

IRCCS S. Maria Nascente, Fondazione Don Carlo Gnocchi ONLUS

Milan, 20148, Italy

Location

Fondazione Don Gnocchi, Centro "S. Maria ai Servi"

Parma, Italy

Location

Related Publications (2)

• Carlomagno C, Bertazioli D, Gualerzi A, Picciolini S, Andrico M, Roda F, Meloni M, Banfi PI, Verde F, Ticozzi N, Silani V, Messina E, Bedoni M. Identification of the Raman Salivary Fingerprint of Parkinson's Disease Through the Spectroscopic- Computational Combinatory Approach. Front Neurosci. 2021 Oct 26;15:704963. doi: 10.3389/fnins.2021.704963. eCollection 2021.

  PMID: 34764849 BACKGROUND

• Gualerzi A, Picciolini S, Carlomagno C, Terenzi F, Ramat S, Sorbi S, Bedoni M. Raman profiling of circulating extracellular vesicles for the stratification of Parkinson's patients. Nanomedicine. 2019 Nov;22:102097. doi: 10.1016/j.nano.2019.102097. Epub 2019 Oct 21.

  PMID: 31648040 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva containing DNA. DNA will not be analysed separatly

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alice Gualerzi, PhD

  Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 11, 2022
• Study Start: December 15, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 13, 2025

Record last verified: 2024-01

Locations

IT (4)