RecruitingOBSERVATIONAL

Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

This study is gathering information about a treatment called Deep Brain Stimulation (DBS) using a specific device called the Vercise System. It's for people with Parkinson's disease. Doctors want to understand how well this treatment helps with symptoms and improves quality of life for patients around the world. They will also look at how special computer tools, including Image Guided Programming, help doctors set up the device for each person. The aim is to collect real-world experiences to better understand the benefits of this treatment, as well as how different ways of setting up the device can make a difference.

At a glance

Status

Recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

1,500

Start

04 Mar 2014

Estimated completion

01 Dec 2038

Parkinson's Disease

What is this study about?

Imagine you have Parkinson's disease and are considering a treatment called Deep Brain Stimulation, or DBS. This treatment involves placing a small device, similar to a pacemaker, in your body. It sends gentle electrical pulses to specific areas of your brain to help control movement problems.

This particular study, called the Vercise DBS Registry, isn't a new experiment with the device. Instead, it's like a worldwide collection of experiences. Doctors are gathering information from many patients who are already using Boston Scientific's Vercise DBS System. They want to see how well it's working for people with Parkinson's and how it affects their daily lives and overall well-being.

They're also interested in how doctors use special computer tools, like 'Image Guided Programming' (IGP), to help set up and fine-tune the DBS device. These tools can create a sort of map of your brain to help doctors decide the best way to program the device for your specific needs. By collecting all this information, researchers hope to learn more about how to make this treatment work best for everyone.

Key takeaways

This study is about a Parkinson's disease treatment called Deep Brain Stimulation (DBS) using the Vercise System.
It's a registry, meaning it collects real-world information about how well the device works for patients.
Researchers are interested in how the device helps with symptoms and improves quality of life.
They also want to understand how special computer tools help doctors program the device effectively.
The information gathered will help improve future treatment for people with Parkinson's.
You must be at least 18 years old and meet specific criteria for the Vercise DBS System to participate.

Who may be eligible?

To be part of this study, you generally need to be at least 18 years old. You must also meet the specific requirements for using the Vercise DBS System, as outlined by the device's guidelines in the UK.

There are certain reasons why you might not be able to join. For example, if there are any health conditions or situations listed in the Vercise System's instructions that mean you shouldn't have the device, then you wouldn't be able to take part. Also, if you have significant problems with your memory or thinking, or certain mental health conditions, the research team might decide that the study isn't 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.

Are you 18 years old or older?
Do you have Parkinson's disease?
Are you considering or already using the Vercise DBS System for your treatment?
Do you meet the general health and device-specific requirements for the Vercise DBS System?
Do you have any significant memory, thinking, or serious mental health conditions that might prevent you from joining?
Are you able to attend regular medical check-ups with your doctor?

Answer every question to see your result.

What does participation involve?

As this is a 'registry' study, it mainly involves collecting information about your experience with the Vercise DBS System rather than following a strict set of experimental procedures. If you're eligible and choose to take part, the researchers will assess your symptoms and quality of life before you have the DBS system and then again afterwards. This will involve regular medical check-ups and answering questions about how you feel and how your symptoms have changed. The information gathered will come from your routine medical care and device management. The specific number of visits and their duration would be determined by your treating doctor and the plan they have for managing your DBS system.

Potential risks and benefits

The main benefit of taking part is that the information collected from your experience will help doctors and researchers better understand how the Vercise DBS System works for people with Parkinson's, potentially improving care for others in the future. As this is observational research based on a device already approved for use, any risks would generally be those associated with the DBS procedure and device itself, rather than from special study procedures. You can, of course, withdraw your consent to have your information included in the registry at any time without affecting your medical care.

Locations (84)

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

Neurology and Pain Specialty
Verified postcode
Aliso Viejo, United States· Withdrawn
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
University of Colorado
Verified postcode
Aurora, United States· Recruiting
St. Mary's Hospital and Medical Center
Verified postcode
Grand Junction, United States· Recruiting
University of Florida Shands Hospital
Verified postcode
Gainesville, United States· Recruiting
Mayo Clinic, Jacksonville
Verified postcode
Jacksonville, United States· Withdrawn
University of Miami Hospital
Verified postcode
Miami, United States· Recruiting
Tallahassee Neurological Clinic, PA
Verified postcode
Tallahassee, United States· Withdrawn
University of South Florida
Verified postcode
Tampa, United States· Recruiting
St. Luke Regional Medical Center
Verified postcode
Boise, United States· Recruiting
Rush University Medical Center
Verified postcode
Chicago, United States· Recruiting
Methodist Hospital of Indianapolis
Verified postcode
Indianapolis, United States· Completed

Common questions

What is the Vercise DBS System?

It's a medical device used for Deep Brain Stimulation (DBS) therapy in people with Parkinson's disease. It sends electrical pulses to the brain to help with movement problems.

Is this a new treatment?

No, the Vercise DBS System is already approved and used by patients. This study is collecting information on how well it works in real-world settings.

What is Deep Brain Stimulation (DBS)?

DBS is a treatment where a device is surgically placed in the body, sending electrical signals to specific areas of the brain to help control symptoms of conditions like Parkinson's.

What does 'Image Guided Programming' mean?

It's a special computer tool that helps doctors use detailed images of your brain to precisely set up the DBS device for the best results.

Will taking part change my medical treatment?

No, this study mainly collects information from your regular care. Your doctor will continue to manage your treatment as usual.

How to find out more

Heleen Scholtes

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

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