Observing outcomes of Vercise DBS for treating dystonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather real-world data on the effectiveness of the Vercise™ Deep Brain Stimulation (DBS) Systems developed by Boston Scientific Corporation for patients with dystonia. It will assess improvements in disease symptoms and overall quality of life among participants. The study will include individuals who meet specific eligibility criteria related to the use of the Vercise System. Data collected will help understand the system's impact on patients in a practical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria (IC):

* IC1. Meets criteria established in the locally applicable Vercise System Directions for Use (DFU) for dystonia.
* IC2. At least 7 years old. Parent or guardian consent is required in patients who are younger than 18 years at the time of consent.

Exclusion Criteria (EC):

* EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.

Where it's running

• UZ Gasthuisberg
  Leuven, Belgium Recruiting
• Queen Elizabeth II Health Sciences Center
  Halifax, Canada Recruiting
• University Berlin, Charite Virchow Standort, Wedding
  Berlin, Germany Recruiting
• Uniklinik Köln
  Cologne, Germany Recruiting
• Universitaetsklinikum Dusseldorf
  Düsseldorf, Germany Recruiting
• Universitaetsklinikum Freiburg
  Freiburg im Breisgau, Germany Recruiting

Study contacts

• Study coordinator: Stephanie Delvaux
• Email: BSNClinicalTrials@bsci.com
• Phone: 855-213-9890

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating the relationship between genetic mutations and brain changes in dystonia

  This study is trying to see how genetic changes linked to dystonia affect the brain in people with the condition compared to healthy individuals.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT03428009

• Intraoperative Microelectrode Recordings with MAVEN vs Standard Equipment

  This study tests whether MAVEN can match the recording data collected during DBS surgery for movement disorders using standard equipment.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07868614

• Low-intensity focused ultrasound for movement and seizure disorders

  This trial will try low-intensity focused ultrasound (LIFUS) to see if it can safely change brain activity in people with movement disorders or epilepsy.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT07417280

• Measuring brain network activity to predict and improve outcomes in children with dystonia

  This project will test whether noninvasive brain and muscle recordings, and comparing DBS on versus off, can predict and help improve motor outcomes for children with dystonia.

  Recruiting Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07325175

• Wearable sensors to predict DBS results for people with dystonia

  This study will test whether wearable sensors that record walking patterns before surgery can predict how well deep brain stimulation will work for people with dystonia.

  Recruiting Ruijin Hospital · Shanghai · NCT07323602

• Using GPi brain signals to guide DBS programming for primary dystonia

  This study will test whether recording local field potentials from the globus pallidus interna with the Medtronic Percept device can help guide DBS programming and improve symptoms in adults with primary dystonia.

  Recruiting Newcastle-upon-Tyne Hospitals NHS Trust · Newcastle upon Tyne, Tyne & Wear · NCT07309133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.