RecruitingOBSERVATIONAL

Vercise™ DBS Dystonia Prospective Study

This study is designed to understand how well a specific type of treatment, called Vercise Deep Brain Stimulation (DBS), works for people living with dystonia. Dystonia is a condition that causes involuntary muscle contractions. The Vercise DBS system is a medical device that has already been approved for use. Researchers want to collect information from people who have had this device implanted to help manage their dystonia, observing them in their everyday lives. They will look at how much their symptoms improve and how this device affects their overall quality of life. The aim is to get a clearer picture of the real-world experiences and benefits of this treatment option for people with dystonia. Participants must be at least 7 years old.

At a glance

Status

Recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

300

Start

07 Mar 2016

Estimated completion

01 Dec 2030

Dystonia

What is this study about?

This study is exploring how a treatment called Boston Scientific Vercise™ Deep Brain Stimulation (DBS) helps people who have a condition called dystonia. Dystonia causes your muscles to tighten and move without you wanting them to, which can be challenging. The Vercise™ DBS system is a special device that sends small, gentle electrical signals to specific areas of the brain to help control these movements. This treatment has already been approved for use, which means it has been thoroughly tested for safety and effectiveness.

The main goal of this study is to see how well the Vercise™ DBS system works for people in their everyday lives, once they have had it implanted. The researchers want to gather information about how much people's dystonia symptoms improve after receiving the treatment. They will also look at how the treatment affects their overall quality of life – meaning how it influences their daily activities, independence, and general well-being.

By collecting this information, the study hopes to give us a better understanding of the real-world benefits of the Vercise™ DBS system for people with dystonia. This helps doctors and patients make informed decisions about treatment options and ensures that care continues to improve for those living with this condition.

Key takeaways

This study is about understanding how Deep Brain Stimulation (DBS) helps people with dystonia in their daily lives.
It focuses on a specific, approved device called the Vercise™ DBS system.
The study looks at symptom improvement and overall quality of life.
You must be at least 7 years old to participate.
Participation involves ongoing monitoring during your regular medical appointments.

Who may be eligible?

To join this study, there are a couple of things that need to be true for you or your child.

Firstly, your medical team will need to confirm that the Vercise™ DBS system is a suitable treatment for your dystonia, based on its official instructions and guidelines. This means your doctor will use their judgment and the official advice to see if this treatment is a good fit for your specific situation.

Secondly, you need to be at least 7 years old. If you are under 18, your parent or guardian will need to give their permission for you to take part. On the other hand, you can't join the study if there are any reasons listed in the Vercise™ DBS system's official instructions that would make it unsafe or unsuitable for you to have the device.

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.

I have been diagnosed with dystonia.
My doctor has suggested the Vercise™ DBS system as a suitable treatment for me.
I am at least 7 years old (or my child is at least 7 years old).
I can confirm that there are no medical reasons that prevent me from having the Vercise™ DBS system.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's about observing how you get on after you've already had the Vercise™ DBS system implanted for your dystonia. There won't be any new medication or extra procedures just for the study.

The main part of taking part will involve regular check-ups where your medical team will assess how your dystonia symptoms are doing and how the device is helping you. They will also talk to you about your quality of life – how you feel day-to-day and how independently you can do things.

These assessments will happen during your routine appointments, so it won't typically add extra visits to your clinic schedule. The total duration of your participation will depend on how long your medical team continues to monitor your treatment as part of your standard care, allowing them to gather comprehensive information over time.

Potential risks and benefits

Participating in this study involves continuing with your Vercise™ DBS treatment, which you would be receiving anyway. The main benefit is that your experiences will help doctors and researchers understand more about how well this treatment works for people with dystonia in real-life situations. This information can help improve care for others in the future. As the device is already approved, its known risks and benefits have been thoroughly assessed. However, all medical treatments carry some level of risk, and your medical team will discuss these with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (36)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

AZ Sint-Lucas
Verified postcode
Ghent, Belgium· Terminated
UZ Gasthuisberg
Verified postcode
Leuven, Belgium· Recruiting
Queen Elizabeth II Health Sciences Center
Verified postcode
Halifax, Canada· Recruiting
University Berlin, Charite Virchow Standort, Wedding
Verified postcode
Berlin, Germany· Recruiting
Uniklinik Köln
Verified postcode
Cologne, Germany· Recruiting
Universitaetsklinikum Dusseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
Universitaetsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Universitaetsklinik Eppendorf
Verified postcode
Hamburg, Germany· Recruiting
St. Barbara-Klinik Hamm-Heessen
Verified postcode
Hamm, Germany· Completed
Medizinische Hochschule Hannover MHH
Verified postcode
Hanover, Germany· Recruiting
Universitatsklinikum Campus Kiel
Verified postcode
Kiel, Germany· Recruiting
Johannes Gutenberg Universitaet Mainz
Verified postcode
Mainz, Germany· Terminated

Common questions

What is dystonia?

Dystonia is a condition that causes your muscles to contract or tighten without you wanting them to, leading to repetitive or twisting movements and unusual postures.

What is Deep Brain Stimulation (DBS)?

DBS is a treatment where a small device is placed under the skin, usually near the collarbone, that sends gentle electrical signals through thin wires to specific areas in the brain to help control movements.

Is the Vercise™ DBS device new?

No, the Vercise™ DBS system has already been approved for medical use, meaning it has passed safety and effectiveness checks.

Will I get different treatment if I join the study?

No, you will receive the standard Vercise™ DBS treatment for your dystonia, just as you would if you weren't in the study. The study simply observes how that standard treatment works for you.

Who can take part in this study?

People with dystonia who are at least 7 years old and for whom the Vercise™ DBS system is a suitable treatment can be considered for the study.

How to find out more

Stephanie Delvaux

bsnclinicaltrials@bsci.com 855-213-9890 Official trial record

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