Not yet recruitingNAINTERVENTIONAL

Sensor-Based Optimization of Therapy for Parkinson's Disease Patients With Motor Fluctuations

This study investigates if special body-worn sensors can help doctors fine-tune treatments for people with Parkinson's disease who experience 'motor fluctuations' – times when their medication isn't working as well. Currently, doctors rely on clinic visits and patient diaries, which might not capture what's happening at home. These new sensors continuously monitor movement and provide detailed reports. We believe these reports could help neurologists make better, more personalised adjustments to medication, potentially improving how patients move, their quality of life, and their ability to do daily activities. This research aims to see if using these sensors alongside usual care offers real benefits.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

218

Start

01 Mar 2026

Estimated completion

01 Oct 2028

Parkinson Disease (PD)

What is this study about?

Imagine you have Parkinson's disease, and sometimes your medication doesn't quite hit the mark, leading to 'motor fluctuations' – periods when your movements are stiff or uncontrolled. Doctors currently adjust your medicines based on your clinic visits and what you tell them, perhaps in a diary. But it can be hard to remember everything that happens at home, and a short clinic visit might not show the full picture of your day-to-day challenges.

This study is looking at a new idea: using clever body-worn sensors, like a special watch, that you wear at home. These sensors continuously track your movements and can spot patterns in how your Parkinson's symptoms change throughout the day. The goal is for this information to help your doctor understand much better what's happening with your symptoms when you're at home, not just during clinic appointments. With this extra detail, doctors might be able to adjust your medication more precisely and effectively.

The main aim is to see if using these sensors, in addition to your usual care, can help reduce the amount of 'off' time you experience – those times when your medication isn't working as well and your symptoms are more noticeable. If this study shows that these sensors are helpful and reliable, it could change how people with Parkinson's are looked after in the future, providing more continuous and personalised care, even from a distance.

Key takeaways

The study explores if wearable sensors can help doctors improve Parkinson's treatment.
It aims to better understand motor fluctuations in daily life, outside of clinic visits.
Participants will wear a special sensor and keep a diary for 6 months.
Sensor data might help doctors fine-tune medication for some participants.
The goal is to reduce 'off' times and improve quality of life.
The study involves 4 follow-up contacts over 6 months.

Who may be eligible?

To join this study, you would need to have had Parkinson's disease for at least four years and be between 46 and 83 years old. A key requirement is that you experience what doctors call 'motor fluctuations,' meaning your medication isn't consistently controlling your symptoms throughout the day, and your neurologist thinks your treatment needs adjusting. You also need to be taking L-Dopa medication at least three times a day.

There are certain reasons why someone might not be able to join. For example, if you have severe memory problems (dementia) or other specific types of Parkinson's symptoms that are resistant to standard treatment, you wouldn't be suitable. You also can't be pregnant or breastfeeding, living in a nursing home, or already be taking part in another similar research study.

It's important that you'd be able to consistently use the special sensor device and keep a simple diary, as those are crucial parts of the study. If you're already on more advanced treatments like a pump therapy or have had deep brain stimulation, or plan to have these treatments soon, you wouldn't be able to participate.

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.

Do you have Parkinson's disease and have had it for more than 4 years?
Are you between 46 and 83 years old?
Do you experience 'motor fluctuations' where your medication isn't always working consistently?
Do you take L-Dopa medication at least three times a day?
Does your neurologist think your medication needs adjusting?
Are you able to use a special sensor device and keep a simple diary consistently?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for a total of 6 months. For the entire 6 months, you will wear a special body-worn sensor (a device called the PKG system, which looks like a watch). This device will record your movements continuously. You will also be asked to keep a diary at home to record how you're feeling and your 'off' times.

All participants will have their treatment adjusted according to the usual medical guidelines. However, for some participants (chosen randomly like drawing names from a hat), the information gathered by the body-worn sensor will also be shared with your neurologist to help them make decisions about your medication adjustments. For others, the sensor information won't be shared with the doctor during the study, although you will still wear the device.

During the 6 months, you will have four follow-up contacts. This includes a phone call around 1 month in, and in-person visits to your clinic at the start, at 3 months, and at 6 months. Each participant's involvement in the study will be for 6 months, and the total study will run for about 31 months in different hospitals across France.

Potential risks and benefits

Participating in this study might offer you the potential benefit of having your Parkinson's medication adjusted more precisely, thanks to the detailed information from the body-worn sensor. This could lead to a better control of your 'off' times and a general improvement in your daily life. However, it's also possible that you may not experience any direct benefit. The risks involved are generally low, mainly related to wearing the sensor device, which is already approved for use, and the inconvenience of keeping a diary and attending appointments. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Centre d'investigations cliniques Pitié-Salpêtrière University Hospital
Verified postcode
Paris, France

Common questions

What are 'motor fluctuations'?

Motor fluctuations are when your Parkinson's symptoms, like stiffness or tremor, change throughout the day, often related to when your medication is or isn't working well.

What is the 'PKG system'?

The PKG system is a special body-worn sensor, similar to a watch, that measures your movements to help understand your Parkinson's symptoms at home.

Will my doctor get to see my sensor data?

Only some participants, chosen randomly, will have their sensor data shared with their neurologist to help adjust their treatment during the study.

How long will I need to be involved?

If you join, your participation, including wearing the sensor and attending visits, will last for 6 months.

What if I experience side effects from my medication?

You should always report any side effects or concerns to your study doctor or nurse immediately, just as you would with your regular care.

How to find out more

David Grabli, Professor

david.grabli@aphp.fr 01 42 16 24 61 Official trial record

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