Pain and Autonomic Symptoms in Parkinson's Disease and Atypical Parkinsonisms

NCT ID: NCT05748028

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2025-12-30

Brief Summary

The goal of this observational study is to learn about the impact of the different types of pain and of the domains involved in the autonomic disorders of inpatients and outpatients diagnosed with Parkinson disease (PD) and multiple system atrophy (MSA) admitted to Istituti Clinici Scientifici Maugeri Centers.

The main aims are:

Evaluate the prevalence of pain and characterize it in Parkinson's disease and atypical parkinsonisms (MSA) Evaluate the effect of rehabilitation on pain and autonomic symptoms Evaluate the prevalence of autonomic symptoms in Parkinson's disease and atypical parkinsonisms (MSA) Assess the impact of pain and autonomic symptoms on quality of life. Participants will perform neurological examination, rehabilitation program and clinical scales.

Researchers will compare the two groups of patients (PD and MSA) and the effect of the rehabilitation on pain, autonomic symptoms and quality of life.

Detailed Description

2% of the population over 65 is affected by Parkinson's disease (PD) or parkinsonism. This represents a significant burden on the health service in countries where the elderly represent 1/5 of the general population. In recent years there has been increased attention on the presence of non-motor disorders in PD patients. Among these, pain and autonomic symptoms are more frequently present and contribute to the worsening of disability and quality of life of the affected patient.

How much the presence of pain and autonomic symptoms can affect the rehabilitation outcome and how much the rehabilitation treatment itself can improve the painful or autonomic symptomatology is not known, but rehabilitation has an important role in the management of diseases where there are no real treatments capable of cure or slow down the neurodegenerative process.

In the Maugeri Clinical Scientific Institutes, patients with Parkinson's disease or parkinsonism are hospitalized or followed as outpatients and a personalized rehabilitation setting is ideal for being able to evaluate the patient in a sufficiently wide time frame to be able to appreciate significant changes in clinical parameters.

The greater knowledge of the impact of the different types of pain and of the domains involved in the autonomic dysfunction will help the clinician to better manage the patient's disability and will contribute to the definition of specific rehabilitation strategies aimed to improve the patient's quality of life.

Conditions

Parkinson Disease; Multiple System Atrophy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Parkinson Disease

Patients affected by Parkinson's disease admitted for rehabilitation in Maugeri Clinical Scientific Institutes

Rehabilitation

Intervention Type: OTHER

All patients included in the study will undergo a basic evaluation with a neurological examination, a rehabilitation program to improve strength, coordination, balance, endurance, and the ability to perform activities of daily life.

Administration of Clinical scales

Intervention Type: OTHER

All patients included in the study will be evaluated by clinical scales assessing the disease stage, clinical severity, freezing, motor and non-motor impairment, cognitive impairment, depression, quality of life, autonomic dysfunction, pain.

Multiple System Atrophy

Patients affected by Multiple System Atrophy admitted for rehabilitation in Maugeri Clinical Scientific Institutes

Rehabilitation

Intervention Type: OTHER

All patients included in the study will undergo a basic evaluation with a neurological examination, a rehabilitation program to improve strength, coordination, balance, endurance, and the ability to perform activities of daily life.

Administration of Clinical scales

Intervention Type: OTHER

All patients included in the study will be evaluated by clinical scales assessing the disease stage, clinical severity, freezing, motor and non-motor impairment, cognitive impairment, depression, quality of life, autonomic dysfunction, pain.

Interventions

Rehabilitation

All patients included in the study will undergo a basic evaluation with a neurological examination, a rehabilitation program to improve strength, coordination, balance, endurance, and the ability to perform activities of daily life.

Intervention Type: OTHER

Administration of Clinical scales

All patients included in the study will be evaluated by clinical scales assessing the disease stage, clinical severity, freezing, motor and non-motor impairment, cognitive impairment, depression, quality of life, autonomic dysfunction, pain.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Parkinson's Disease or Multiple System Atrophy according to current international criteria (Gilman S et al, 2008; Postuma RB et al. 2015).
• Mini-Mental State Examination score at least 10

Exclusion Criteria

• vascular or pharmacological parkinsonism
• diabetes mellitus
• hepatic or renal dysmetabolism,
• hypothyroidism or hyperthyroidism
• assumption of potentially neurotoxic drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Nolano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Isituti Clinici Scientifici Maugeri SpA SB - IRCCS of Telese Terme

Locations

ICS Maugeri - IRCCS of Telese Terme

Telese Terme, Benevento, Italy

Site Status: RECRUITING

ICS Maugeri - Lumezzane

Lumezzane, Brescia, Italy

Site Status: RECRUITING

ICS Maugeri - Castelgoffredo

Castel Goffredo, Mantova, Italy

Site Status: RECRUITING

ICS Maugeri - Mistretta

Mistretta, Messina, Italy

Site Status: RECRUITING

ICS Maugeri - Veruno

Veruno, Novara, Italy

Site Status: RECRUITING

ICS Maugeri - Montescano

Montescano, Pavia, Italy

Site Status: RECRUITING

ICS Maugeri - Milano

Milan, , Italy

Site Status: RECRUITING

ICS Maugeri - Pavia Boezio

Pavia, , Italy

Site Status: RECRUITING

ICS Maugeri - Pavia

Pavia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Nolano, MD, PhD

Role: CONTACT

maria.nolano@icsmaugeri.it

+390824909257

Giuseppe Caporaso

Role: CONTACT

giuseppe.caporaso@icsmaugeri.it

+390824909645

Facility Contacts

Vincenzo Provitera, MD

Role: primary

vincenzo.provitera@icsmaugeri.it

+390824909257

Diego Ghianda, MD

Role: primary

diego.ghianda@icsmaugeri.it

0308253186

Giuliana Vezzadini, MD

Role: primary

giuliana.vezzadini@icsmaugeri.it

037677471

Paolo Volanti, MD

Role: primary

paolo.volanti@icsmaugeri.it

0921389574

Giorgio Maggioni, MD

Role: primary

giorgio.maggioni@icsmaugeri.it

0322884711

Cira Fundarò, MD

Role: primary

cira.fundaro@icsmaugeri.it

0385247268

Beatrice De Maria, Eng

Role: primary

beatrice.demaria@icsmaugeri.it

0250725260

Marianna Loi, MD

Role: primary

marianna.loi@icsmaugeri.it

+3903825931

Isabella Springhetti, MD

Role: primary

isabella.springhetti@icsmaugeri.it

+390382592621

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PMID: 23716362 (View on PubMed)

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Reference Type: BACKGROUND

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Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.

Reference Type: BACKGROUND

PMID: 26474316 (View on PubMed)

Gilman S, Wenning GK, Low PA, Brooks DJ, Mathias CJ, Trojanowski JQ, Wood NW, Colosimo C, Durr A, Fowler CJ, Kaufmann H, Klockgether T, Lees A, Poewe W, Quinn N, Revesz T, Robertson D, Sandroni P, Seppi K, Vidailhet M. Second consensus statement on the diagnosis of multiple system atrophy. Neurology. 2008 Aug 26;71(9):670-6. doi: 10.1212/01.wnl.0000324625.00404.15.

Reference Type: BACKGROUND

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Other Identifiers

SBLAB1/19

Identifier Type: -

Identifier Source: org_study_id