RecruitingOBSERVATIONAL

International Validation of Two Non-motor Scales in PD (NFS and SPARK)

This study aims to improve how we understand and measure the many ways Parkinson's disease (PD) can affect people, beyond the physical movements. Researchers are working on two new questionnaires: one to track changes in mood and thinking skills, and another to understand feelings of shame often experienced by people with PD. These questionnaires are being tested internationally in several countries, including Spain, Germany, and France. By making these tools widely available and reliable, doctors will have a better way to assess all symptoms, leading to more tailored and effective care for people living with Parkinson's. This could greatly improve the quality of life for those with the condition.

At a glance

Status

Recruiting

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrolment target

300

Start

03 Dec 2020

Estimated completion

31 Dec 2025

Parkinson's Disease Non-motor Symptoms

What is this study about?

This research project is all about getting a clearer picture of how Parkinson's disease affects people every day. We know Parkinson's can cause movement problems, but it can also bring about other 'hidden' symptoms, like changes in mood, thinking, and even feelings of shame. These are called non-motor symptoms, and they can have a big impact on a person's life, but they aren’t always easy to talk about or measure.

The study is developing two new questionnaires to help doctors and researchers understand these hidden symptoms better. One is called the Neuropsychiatric Fluctuations Scale (NFS), which looks at how mood and thinking might change when a person's Parkinson's medication wears off and on. The other is the Shame in Parkinson's disease (SPARK) Scale, which focuses on feelings of shame or embarrassment that can come with living with Parkinson's. These feelings might relate to symptoms, needing help, or changes in how one sees themselves. Currently, there aren't many good ways to measure these specific feelings in Parkinson's.

By testing these questionnaires with people with Parkinson's in different countries, the researchers hope to make them reliable and useful worldwide. The goal is that these new tools will help medical teams understand the full range of symptoms, both seen and unseen. This better understanding can then lead to more personalised and effective ways to help people manage their Parkinson's and improve their quality of life.

Key takeaways

New questionnaires are being developed to understand Parkinson's better.
The study focuses on 'hidden' symptoms like mood changes and feelings of shame.
It aims to give doctors better tools to assess symptoms and improve care.
People aged 30-75 with Parkinson's (without dementia) can take part.
Participation involves answering questions about your experiences.
Your input could help many others with Parkinson's in the future.

Who may be eligible?

To take part in this study, you need to have been diagnosed with Parkinson's disease using specific medical guidelines. You also need to be aged between 30 and 75 years old.

It's important that you can understand and speak the language in which the questionnaires are given. Before joining, you will be asked to read and sign a consent form, which means you agree to take part and understand what is involved.

You cannot join this study if you have been diagnosed with Parkinson's dementia. This is usually checked with a short test that looks at your thinking and memory skills.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with Parkinson's disease.
I am between 30 and 75 years old.
I can speak and understand the language of the questionnaires.
I have not been diagnosed with Parkinson's dementia.

Answer every question to see your result.

What does participation involve?

This study involves answering questions from two new questionnaires. You will likely meet with researchers or clinic staff who will guide you through these questions. The questionnaires cover topics related to your mood, thinking, and feelings about living with Parkinson's. These are 'rating scales', meaning you'll be asked to rate how often or how strongly you experience certain things. The study is collecting information from patients at different times, often in conjunction with your regular clinic visits. The total duration for your involvement will depend on the study design, but generally, this type of questionnaire-based study might involve one or a few visits over a shorter period rather than long-term follow-up.

Potential risks and benefits

Taking part in this study may not directly help you right away, but the information you provide will help doctors better understand Parkinson's disease and its wider effects in the future. This could lead to improved care for many people with Parkinson's. There are very few risks expected, mainly that answering questions about personal feelings might be emotionally uncomfortable for some. You are free to stop taking part at any time without giving a reason, and this will not affect your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Centre hospitalier régional universitaire de Besançon
Verified postcode
Besançon, France· Completed
Universitätsklinikum Carl Gustav Carus
Verified postcode
Dresden, Germany· Completed
Aristotle University of Thessaloniki
Verified postcode
Thessaloniki, Greece· Completed
Transilvania University
Verified postcode
Brasov, Romania· Recruiting
Hospital Universitario Burgos
Verified postcode
Burgos, Spain· Completed
Ruber International Hospital
Verified postcode
Madrid, Spain· Completed
Insel Gruppe AG University Hospital Bern
Verified postcode
Bern, Switzerland· Completed
King's College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What are 'non-motor symptoms'?

These are symptoms of Parkinson's disease that don't involve movement, such as changes in mood, memory, sleep, or feelings like shame.

What is a 'rating scale'?

It's like a questionnaire where you rate how often you experience something or how much it affects you, for example, on a scale of 0 to 5.

Why is this study important?

It's important because it creates new tools to help doctors properly understand and measure all the ways Parkinson's affects people, including hidden symptoms like feelings of shame or mood changes. This helps improve future care.

Will I get any medicine in this study?

No, this study is about answering questions using questionnaires, not about testing new medicines. It's focused on understanding symptoms better.

What does 'international validation' mean?

It means the questionnaires are being tested in different countries and languages to make sure they are useful and accurate for people with Parkinson's all over the world.

How to find out more

Ines Debove, MD

ines.debove@insel.ch +41 31 63 2 79 24 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.