RecruitingNAINTERVENTIONAL

Study of the Test-retest Reliability of the Neuropsychiatric Fluctuations Scale in Parkinson's Disease

This study is testing a new questionnaire called the Neuropsychiatric Fluctuations Scale (NFS) for people with Parkinson's disease. It helps understand and track sudden changes in mood, thinking, and behaviour, like feeling very low or very active, which can happen with Parkinson's. These changes, called neuropsychiatric fluctuations (NPF), can significantly affect daily life for patients and their families. We've already shown the NFS works well, and now we're doing a final check to make sure it gives consistent results over time. This will help doctors use it reliably to diagnose and manage these important symptoms, ultimately aiming to improve the quality of life for those living with Parkinson's.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Grenoble

Enrolment target

100

Start

01 Feb 2025

Estimated completion

01 Mar 2027

Parkinson's Disease

What is this study about?

Parkinson's disease can sometimes cause more than just movement problems. Many people with Parkinson's also experience sudden changes in their mood, energy, and thinking – these are called 'neuropsychiatric fluctuations' (NPF). For example, someone might switch quickly from feeling very low, anxious, or apathetic to feeling unusually active, impulsive, or have trouble paying attention. These changes can be really challenging for the person with Parkinson's and their caregivers, and they can also lead to other issues like relying too much on certain medications.

Because there wasn't a specific, easy-to-use tool to understand these NPFs, our team developed a new questionnaire. It's called the Neuropsychiatric Fluctuations Scale (NFS), and it's a list of 20 questions designed to help spot these sudden ups and downs. We've already done some important checks and found that this questionnaire is good at identifying NPFs and gives useful information to doctors. Experts have even published our findings in medical journals.

Now, we're doing a final crucial step to make sure the NFS is ready for wider use. This study is like a final 'double-check' to see if the questionnaire gives the same results when someone fills it out at different times, assuming their condition hasn't changed. This is called 'test-retest reliability'. If it passes this check, it means doctors can trust the NFS to be a consistent and valuable tool for understanding, diagnosing, and helping to manage these important symptoms in people with Parkinson's.

Key takeaways

This study is testing a new way to understand mood and thinking changes in Parkinson's.
It uses a special questionnaire called the Neuropsychiatric Fluctuations Scale (NFS).
The goal is to make sure the questionnaire gives reliable results consistently.
Participation involves filling out this questionnaire twice and a physical check-up.
This research aims to improve care and quality of life for people with Parkinson's.

Who may be eligible?

To be part of this study, you would generally need to be between 30 and 75 years old and have been diagnosed with Parkinson's disease (specifically, the most common type, called 'idiopathic' Parkinson's). It's important that you or your family have noticed some changes in your movement, either yourself or your doctor has. Your Parkinson's medication should also have been stable for at least a month before joining.

You'll also need to be able to speak French well enough to understand and answer the questions, and you must be able to agree to take part in the study voluntarily. Finally, you should be covered by the social security system in France.

You wouldn't be able to join if your Parkinson's is due to another known cause, or if you have severe memory or thinking problems (doctors call this 'dementia'). If you are not on Parkinson's medication, or if your medication has changed recently (within the last month), you wouldn't be eligible. Also, certain people who are considered vulnerable, such as pregnant women, those in prison, or people in psychiatric care, cannot take part. If you're already in another medical study that involves treatment or interventions, you wouldn't be able to join this one.

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.

Are you between 30 and 75 years old?
Do you have idiopathic Parkinson's disease?
Have you or your family noticed sudden changes in your movement or mood?
Has your Parkinson's medication been stable for at least one month?
Are you able to understand and speak French?
Do you have social security coverage?

Answer every question to see your result.

What does participation involve?

Taking part in this study primarily involves answering a questionnaire. You would complete the Neuropsychiatric Fluctuations Scale (NFS) questionnaire at two separate times. There will also be a physical examination as part of your participation. The study does not involve any changes to your current Parkinson's medication or any new treatments. The exact timing between completing the questionnaire twice will be determined by the study team, but the overall involvement will be relatively short-term, focusing on these two questionnaire completions and the physical exam. There is no long-term follow-up beyond the short period needed for these assessments.

Potential risks and benefits

The main benefit of taking part is contributing to important research that will help improve how doctors understand and manage sudden mood and thinking changes in people with Parkinson's disease. This could lead to better care for many people in the future. As this study mainly involves filling out a questionnaire and a physical exam, any risks are expected to be very low. Some people might find answering the questions about their mood and behaviours a bit tiring or emotional, but you can always take a break or stop if you feel uncomfortable. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHUGA
Verified postcode
Grenoble, France· Recruiting

Common questions

What are 'neuropsychiatric fluctuations'?

These are sudden and sometimes quick changes in a person's mood, behaviour, or thinking, like switching from feeling very low to very active, which can happen to people with Parkinson's.

What is the Neuropsychiatric Fluctuations Scale (NFS)?

It's a new 20-question survey designed to help doctors understand and track these sudden changes more accurately.

Why is this study important?

This study is the final step to make sure the NFS questionnaire is reliable and gives consistent results, so doctors can use it effectively to help people with Parkinson's.

Will I receive any new medication or treatment in this study?

No, this study only involves completing questionnaires and a physical exam; it doesn't include any new treatments or changes to your current medication.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Emmanuelle Schmitt, PHD

eschmitt@chu-grenoble.fr +33 4 76765791 Official trial record

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