RecruitingNAINTERVENTIONAL

Subthalamic Nucleus, Akinesia and Parkinson's Disease

This study is exploring a small, deep part of the brain called the subthalamic nucleus, or STN. We're trying to understand its role in controlling movement in people who are healthy and in those living with Parkinson's disease. Specifically, we want to find out why movement problems, like slowness or difficulty starting to move (called akinesia), happen in Parkinson's disease. We also want to learn how a treatment that gently stimulates the STN can help improve these movement difficulties. This research aims to give us a clearer picture of how Parkinson's affects the brain and how this type of stimulation might offer a solution.

At a glance

Status

Recruiting

Phase

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrolment target

180

Start

01 Feb 2013

Estimated completion

01 Aug 2025

Parkinson's Disease

What is this study about?

This research is looking at a specific, small part of your brain called the subthalamic nucleus (STN). Think of the STN as a tiny control center deep inside your brain that helps manage your movements. In people with Parkinson's disease, this control center doesn't always work as it should, leading to common symptoms like stiffness, slowness, and difficulties with moving. This study wants to understand exactly how the STN works in healthy people and how it goes wrong in Parkinson's.

One of the main goals is to figure out why some movement problems, particularly a condition called akinesia (which means difficulty starting to move), happen in Parkinson's. Researchers are also very interested in how stimulating the STN can make these movement problems better. This involves placing very thin wires, or electrodes, into the brain that deliver small electrical pulses to the STN. This type of treatment is sometimes suggested for people with Parkinson's when their medications aren't working as well as they used to.

By carefully studying the STN and the effects of this stimulation, the researchers hope to gain a much better understanding of Parkinson's disease. This knowledge could help doctors improve existing treatments and potentially develop new ones in the future, ultimately making a real difference to people living with Parkinson's.

Key takeaways

This study explores a brain area called the STN and its role in Parkinson's movement.
It aims to understand why movement problems occur and how brain stimulation can help.
Participants must be 18-70 years old with confirmed Parkinson's disease.
Some participants will undergo brain stimulation surgery; others will not.
Your health and safety are carefully considered for eligibility.
Your participation could help advance Parkinson's research for future patients.

Who may be eligible?

To join this study, whether you are having surgery or not, you generally need to be between 18 and 70 years old and have a confirmed diagnosis of Parkinson's disease by UK Parkinson's Society Brain Bank standards. You also need to be in overall good health, with no major health issues that would make taking part unsafe or interfere with the study's procedures. Importantly, your brain scans (MRI) should not show any major problems.

If you are considering surgery as part of the study, you would typically have significant movement problems like 'wearing off' periods (where medication stops working) or uncontrolled movements (dyskinesias) despite taking your best medications. You'd also need to show a good response to your levodopa medication. For all participants, you'll need to understand what the study involves and willingly agree to take part by signing a consent form.

There are also some reasons why you wouldn't be able to join. These include having a significant mental health condition, dementia, any medical issue that would make surgery dangerous, or problems with blood clotting. You also can't have certain metal implants (like pacemakers) that would make MRI scans unsafe, or be taking specific medications that interact with blood clotting. People under guardianship or similar legal measures also can't 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.

Are you between 18 and 70 years old?
Do you have a diagnosis of Parkinson's disease?
Do you have stable health conditions and no major brain abnormalities on MRI?
If you have Parkinson's, do you experience movement fluctuations or dyskinesias despite medication?
Are you able to provide consent and understand the study after it's explained to you?

Answer every question to see your result.

What does participation involve?

The detailed involvement for this study isn't fully outlined, but generally, studies like this involve several visits to a hospital or clinic. These visits would likely include various assessments of your movement and brain function before and after any treatment. You might undergo brain scans, like an MRI, and tests of your movements and coordination. If you are part of the group having surgery, this would involve the operation itself, followed by appointments to adjust the stimulation device. The total duration of participation isn't specified but typically involves follow-up appointments over several months or even years to monitor the effects of stimulation and track your progress.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your participation could help researchers learn more about Parkinson's disease, which could lead to better treatments for others in the future. Potential risks, especially for those undergoing surgery, include those associated with any brain operation, such as infection or bleeding, though these are rare. There's also the risk of potential side effects from brain stimulation, which would be explained to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

CIC-GHPS
Verified postcode
Paris, France· Recruiting
Groupe Hospitalier Pitie-Salpêtrière
Verified postcode
Paris, France· Recruiting

Common questions

What is the subthalamic nucleus (STN)?

It's a tiny, deep area in your brain that plays a key role in controlling your movements.

What are 'akinesia' and 'dyskinesia'?

Akinesia means difficulty starting to move or very slow movement. Dyskinesia refers to uncontrolled, jerky movements that can be a side effect of Parkinson's medication.

What is 'bilateral subthalamic stimulation'?

This is a treatment that involves placing thin wires into both sides of your brain's STN to deliver small electrical pulses, helping to improve movement symptoms.

Will I have to have surgery if I join this study?

This study includes both patients who will have surgery and those who won't. You will be told which group you might be in based on the study's specific needs and your health condition.

Will my regular Parkinson's medication change if I join?

The study aims to see how STN stimulation improves symptoms, so changes to your medication might be part of the study, especially for those having surgery. This would be carefully managed by your doctors.

How to find out more

Marie-Laure Welter, MD, PhD

marielaure.welter@icm-institute.org Official trial record

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