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Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)

This study is gathering information about people who have Essential Tremor and are being treated with Deep Brain Stimulation (DBS) systems made by Boston Scientific. Essential Tremor is a condition that causes uncontrollable shaking. DBS involves placing small devices in the brain to help control these tremors. The maingoal of this study is to see how well these systems actually work for patients in their daily lives, outside of clinical trials. It's looking at people who are already using these approved devices as directed by their doctors. The information collected will add to what we already know about how effectively DBS can help to reduce the symptoms of Essential Tremor.

At a glance

Status
Recruiting
Sponsor
Boston Scientific Corporation
Enrolment target
500
Start
23 Oct 2019
Estimated completion
01 Dec 2029

What is this study about?

This study is about a medical treatment called Deep Brain Stimulation, often shortened to DBS. DBS is used to help people who have Essential Tremor, which is a condition that causes uncontrollable shaking, usually in the hands and arms. We know that DBS can be an effective treatment, and this study aims to understand how well Boston Scientific's DBS systems work for patients in their day-to-day lives.

Imagine a 'registry' as a collection of information. This study is building a registry of people with Essential Tremor who are already using Boston Scientific's DBS devices. It's not a study where new treatments are being tested; instead, it's observing people who are already being treated with these approved devices according to their doctor's instructions. By doing this, the researchers can see what the 'real-world' outcomes are like.

The main reason for collecting this information is to get a clearer picture of how DBS helps people with Essential Tremor. This helps doctors and patients make informed decisions about treatment options. The more information we have about how a treatment performs in real-life situations, the better we can understand its benefits and challenges for different individuals.

Key takeaways

  • This study collects real-world information on DBS for Essential Tremor.
  • It focuses on Boston Scientific's approved DBS systems.
  • You must already be using DBS for Essential Tremor to be eligible.
  • Participation involves sharing medical information, not new procedures.
  • The goal is to better understand long-term treatment outcomes.

Who may be eligible?

To join this study, you must be at least 18 years old. Also, the Deep Brain Stimulation (DBS) system you are using must meet the specific requirements set out in the device's official instructions for treating Essential Tremor in your local area. This means your doctor would have looked at these criteria when deciding if DBS was right 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.

  1. I am at least 18 years old.
  2. I have been diagnosed with Essential Tremor.
  3. I am currently being treated with a Boston Scientific Deep Brain Stimulation (DBS) system.
  4. My DBS treatment meets the official instructions for treating Essential Tremor in my area.
Answer every question to see your result.

What does participation involve?

This study is collecting information from people who are already using a Boston Scientific Deep Brain Stimulation (DBS) system for Essential Tremor. This means you wouldn't be undergoing new procedures or taking new medications specifically for this study. The researchers will simply be gathering information about your progress and how the DBS system is working for you during your regular medical care. The total duration of your involvement would depend on how long the study continues to collect this real-world data, but it primarily involves allowing your medical information related to DBS to be collected and recorded.

Potential risks and benefits

The main benefit of taking part in this study is that the information gathered will help improve our understanding of how Deep Brain Stimulation (DBS) works for Essential Tremor in the long term. This can help future patients and doctors. Since you would already be using DBS as part of your regular treatment, there are no additional medical risks specifically from participating in this registry, beyond the usual risks associated with DBS treatment itself. You are always free to decide to withdraw your consent for your information to be included at any time, without it affecting your medical care.

Locations (20)

  • A.o. LKH Univ.-Kliniken Innsbruck
    Verified postcode
    Innsbruck, Austria· Recruiting
  • AZ Sint-Lucas
    Verified postcode
    Ghent, Belgium· Recruiting
  • UZ Gasthuisberg
    Verified postcode
    Leuven, Belgium· Recruiting
  • AZ Delta
    Verified postcode
    Roeselare, Belgium· Recruiting
  • Vancouver General Hospital
    Verified postcode
    Vancouver, Canada· Recruiting
  • Uniklinik Koln
    Verified postcode
    Cologne, Germany· Recruiting
  • Universitaetsklinikum Dusseldorf
    Verified postcode
    Düsseldorf, Germany· Recruiting
  • Universitaetsklinikum Essen
    Verified postcode
    Essen, Germany· Recruiting
  • Universitatsklinikum Campus Kiel
    Verified postcode
    Kiel, Germany· Recruiting
  • Universitaetsklinikum Giessen und Marburg GmbH
    Verified postcode
    Marburg, Germany· Recruiting
  • Evangelisches Krankenhaus Oldenburg
    Verified postcode
    Oldenburg, Germany· Recruiting
  • Universitaetsklinikum Wuerzburg
    Verified postcode
    Würzburg, Germany· Recruiting

Common questions

What is Essential Tremor?

Essential Tremor is a condition that causes uncontrolled shaking, most often in the hands, but it can affect other parts of the body too.

What is Deep Brain Stimulation (DBS)?

DBS is a treatment where small medical devices are placed in the brain to help control tremors by sending electrical signals.

Do I have to do anything special if I join this study?

No, you don't. This study just collects information from your routine medical care regarding your DBS treatment.

Will this study change my medical treatment?

No, your medical treatment will continue as normal, decided by you and your doctor. This study just observes.

Who is running this study?

This study is sponsored by Boston Scientific, the company that makes the DBS systems being observed.

How to find out more

Stephanie Delvaux

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 "Boston Scientific Registry of Deep Brain Stimulation for Tre…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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