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Not yet recruitingNAINTERVENTIONAL

Characterization of the Involvement of the Subthalamic Nucleus During Wakefulness and Sleep in Parkinson's Disease: Contribution of Deep Brain Stimulation

Sleep problems are common and can be difficult for people with Parkinson's disease. This study aims to understand how a small area deep inside the brain, called the subthalamic nucleus (STN), affects sleep and being awake in people with Parkinson's. Researchers are building on earlier work with animals that showed similar sleep issues to those seen in humans. They want to find out if the electrical signals from the STN can give clues about sleep disturbances. The ultimate goal is to improve deep brain stimulation (DBS) – a treatment already used for Parkinson's movement symptoms – so it can also help manage sleep issues more effectively. This could lead to a 'smart' DBS system that adjusts itself based on your sleep patterns.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
University Hospital, Grenoble
Enrolment target
15
Start
01 Jul 2026
Estimated completion
01 Jul 2029
Parkinson Disease

What is this study about?

Many people with Parkinson's disease experience difficulties with their sleep and wakefulness, which can significantly affect their daily lives and overall health. These problems range from trouble falling asleep, staying asleep, or feeling tired during the day. This study is designed to explore a specific part of the brain, called the subthalamic nucleus (STN), and its role in these sleep and wake issues in people with Parkinson's.

Scientists have been looking at this area because previous research, including studies with animals, showed that the STN might be involved not just in movement, but also in sleep. For people who have deep brain stimulation (DBS) surgery for Parkinson's, doctors place thin wires (electrodes) into the STN. This study will use the signals from these electrodes to learn more about how the STN behaves during sleep and wakefulness in people with Parkinson's.

The main aim is to better understand why sleep problems happen and how the STN is involved. This knowledge could help doctors improve existing DBS treatments, potentially leading to new ways to specifically tackle sleep disturbances. The hope is to develop a more advanced type of DBS that can adapt and respond to a person's individual sleep and wake patterns, making the treatment more effective for a wider range of Parkinson's symptoms.

Key takeaways

  • Aims to understand sleep problems in Parkinson's.
  • Focuses on a brain area called the subthalamic nucleus (STN).
  • Uses existing Deep Brain Stimulation (DBS) electrodes for research.
  • Hopes to improve DBS to also help with sleep disturbances.
  • You must be eligible for DBS surgery for Parkinson's and attend Grenoble University Hospital.
  • Requires ability to speak and understand French.

Who may be eligible?

To be considered for this study, you must be an adult with Parkinson's disease who is already attending Grenoble University Hospital in France. A key requirement is that your doctor has decided you would benefit from deep brain stimulation (DBS) surgery, specifically in the subthalamic nucleus (STN).

You must also agree to have a specific type of stimulator device called a Medtronic PERCEPT implanted as part of your usual care. It's important that you are able to understand and speak French so you can complete any study questionnaires. Lastly, you'll need to sign a consent form, showing you understand and agree to take part, and be covered by a social security scheme.

There are also some reasons why you might not be able to join. For example, if you have conditions like severe memory problems (dementia) or serious depression that might make it unsafe or difficult for you to participate fully. If you're currently in another study or if the doctors feel that for any reason you shouldn't take part, you wouldn't be eligible.

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.

  1. Are you an adult with Parkinson's disease?
  2. Are you receiving care at Grenoble University Hospital?
  3. Has your doctor said you're a good candidate for STN Deep Brain Stimulation (DBS) surgery?
  4. Are you able to understand and speak French?
  5. Are you covered by social security or a similar health scheme?
  6. Do you have any serious memory problems or severe depression?
Answer every question to see your result.

What does participation involve?

This is a pilot study, meaning it's a smaller study designed to find new information before a larger one. You would be participating if you are already scheduled for deep brain stimulation surgery for Parkinson's disease at Grenoble University Hospital. Aside from your usual surgery, the study primarily involves using the signals from the deep brain stimulation electrodes that are implanted during your routine care. There are no additional medications or treatments given specifically for this study. The researchers will be collecting information about your sleep and wake patterns. The exact number of visits and the full duration of follow-up for the study itself are not detailed, but it would align with your standard post-surgery care, with additional data collection happening during that time.

Potential risks and benefits

Potential benefits of participating include helping researchers gain a better understanding of how deep brain stimulation might improve sleep disturbances in Parkinson's, which could lead to better treatments in the future. You wouldn't receive specific individual benefits from participating in this pilot study, as it's primarily for research knowledge. The risks involved are mainly those associated with the deep brain stimulation surgery itself, which is part of your standard care, rather than specific risks from the study procedures, which focus on collecting data from the implanted device. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Neurosurgery Department
    Verified postcode
    Grenoble, France

Common questions

What is the subthalamic nucleus (STN) and why is it important?

The STN is a small area deep in your brain that plays a role in movement. Researchers are now looking at how it might also affect sleep and wakefulness in Parkinson's.

What is Deep Brain Stimulation (DBS)?

DBS is a treatment for Parkinson's disease where small wires are placed in specific brain areas, like the STN, to send electrical signals and help control movement symptoms.

Will taking part in this study change my Parkinson's treatment?

No, this study uses information from the DBS device you're already receiving as part of your standard care. It won't change your current Parkinson's treatment plan.

What will researchers do with the information they collect?

They will analyze the brain signals from your DBS device to understand how the STN affects sleep in Parkinson's and hopefully develop better 'smart' DBS treatments in the future.

Do I have to speak French to participate?

Yes, as the study involves questionnaires, you need to be able to understand and communicate in French.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "Characterization of the Involvement of the Subthalamic Nucle…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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