RecruitingOBSERVATIONAL

Chronic Outcome Monitoring for DBS in Dystonia

Dystonia is a condition that causes unwanted muscle movements, making everyday tasks difficult. Deep Brain Stimulation (DBS) is a treatment that places small wires in the brain to send electrical signals, controlled by a small device (like a pacemaker) under the skin. While DBS can be very helpful, it often takes a long time to find the best settings for each person. This study aims to make DBS treatment better and quicker. We are monitoring brain activity for 12 months using a special pacemaker. By understanding how brain signals change over time and how they relate to symptoms, we hope to find ways to tailor the treatment more effectively. This could mean faster relief from symptoms for people with dystonia in the future.

At a glance

Status

Recruiting

Sponsor

Charite University, Berlin, Germany

Enrolment target

Start

16 Aug 2024

Estimated completion

30 Mar 2028

Dystonia

What is this study about?

Dystonia is a condition where your muscles tighten, twist, and repeat movements, causing unusual postures or difficult movements. It can affect different parts of the body and can range from mild to severe, making daily life challenging. One treatment option is Deep Brain Stimulation (DBS). This involves a minor operation to place thin wires (electrodes) in specific areas of the brain. These wires are connected to a small device, like a pacemaker, placed under the skin, usually in the chest. This device sends gentle electrical pulses to the brain to help control the abnormal movements.

While DBS has been shown to be effective, figuring out the best settings for each person's pacemaker can take many months. This is because every person's brain and dystonia are unique. This study is designed to learn more about how DBS works in the long term, specifically by looking at electrical signals in the brain. We believe that by understanding these signals better, we can develop ways to find the best treatment settings much faster than before.

To do this, we will be using a special type of pacemaker that not only delivers electrical pulses but can also record brain activity. Participants will have their brain activity monitored for a year. At the same time, we'll keep track of their symptoms through questionnaires and a video diary. By putting all this information together, we hope to identify specific brain signals that tell us how well the treatment is working and help doctors adjust the DBS settings more precisely and quickly for future patients. This could lead to a significant improvement in how people with dystonia experience their treatment.

Key takeaways

This study is for people with dystonia receiving DBS surgery.
It aims to make DBS treatment more effective and quicker to optimise.
A special pacemaker will record brain activity for 12 months.
You'll track symptoms weekly via an app and attend monthly hospital visits.
The research could lead to personalised DBS treatment for future patients.

Who may be eligible?

This study is looking for people with dystonia who are considering Deep Brain Stimulation (DBS) surgery. You must be between 5 and 80 years old. An important part of joining is that you are planning to have a specific type of DBS device implanted — the Percept neurostimulator, which can both stimulate and record brain activity.

If you are a child, your parent or legal guardian must be happy to give permission for you to take part. All participants, or their guardians, must be able to understand the study and agree to join.

However, this study might not be right for you if you have severe mental health conditions (like very strong depression or anxiety, as measured by a specific score) or other serious medical problems that could make it difficult for you to participate fully in what the study asks. Your doctor will be able to help decide if this study is suitable for you.

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 dystonia?
Are you between 5 and 80 years old?
Are you planning to have DBS surgery using a ‘Percept’ device?
Are you able to agree to take part, or is your guardian willing to for you?
Do you not have severe mental health issues that would stop you from participating?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will already be having the Deep Brain Stimulation (DBS) surgery. The main extra activity involves your special pacemaker recording your brain activity for 12 months. Alongside this, you'll record your symptoms every week using a special app on a device, which includes answering questions and making a short video diary.

You will also have monthly appointments at the hospital. During these visits, doctors will save the brain activity data from your pacemaker. They will also assess your movements both when you are resting and when you perform a simple task like finger tapping. This helps us understand how your symptoms are changing and if there are any side effects from the stimulation. The total duration of active participation in the study is 12 months.

Potential risks and benefits

Taking part in this study might help us understand dystonia and DBS treatment better for everyone in the future, potentially leading to faster and more effective treatment adjustments. For you personally, there might not be a direct benefit beyond your standard DBS treatment, but the detailed monitoring could provide your care team with extra information about your condition. As with any medical procedure, having DBS surgery carries its own risks, which your surgeon will discuss with you. The additional recordings for this study are generally considered safe, but there's a small risk of discomfort from the monitoring equipment or from the regular appointments. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Recruiting
Heinrich Heine University
Verified postcode
Düsseldorf, Germany· Recruiting
Charité Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is dystonia?

Dystonia is a movement disorder where your muscles spasm, causing repetitive movements and unusual postures.

What is Deep Brain Stimulation (DBS)?

DBS is a treatment for certain movement disorders, where small wires are placed in the brain to send electrical signals, controlled by a small device like a pacemaker.

Why is this study important?

This study aims to use brain recordings from your DBS device to find better and faster ways to adjust your treatment settings, making DBS more effective for people with dystonia.

How long will I be in the study?

If you join, you will be part of the study for 12 months after your DBS surgery.

Will I have extra operations for this study?

No, you will not have extra operations. The brain activity recording is done through the same device that delivers your DBS treatment, which you would be having anyway.

How to find out more

Andrea A Kuehn, MD

andrea.kuehn@charite.de 0049 30 450 660 203 Official trial record

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