Vercise™ DBS Dystonia Prospective Study

August 4, 2026 updated by: Boston Scientific Corporation

Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia

To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.

Subjects' improvement in disease symptoms and overall Quality of life will be assessed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium
        • Terminated
        • AZ Sint-Lucas
      • Leuven, Belgium
        • Recruiting
        • Uz Gasthuisberg
        • Contact:
  • Canada
      • Halifax, Canada
        • Recruiting
        • Queen Elizabeth II Health Sciences Center
        • Contact:
  • Germany
      • Berlin, Germany
        • Recruiting
        • University Berlin, Charite Virchow Standort, Wedding
        • Contact:
      • Cologne, Germany
        • Recruiting
        • Uniklinik Köln
        • Contact:
      • Düsseldorf, Germany
        • Recruiting
        • Universitaetsklinikum Dusseldorf
        • Contact:
      • Freiburg im Breisgau, Germany
        • Recruiting
        • Universitaetsklinikum Freiburg
        • Contact:
      • Hamburg, Germany
        • Recruiting
        • Universitaetsklinik Eppendorf
        • Contact:
      • Hamm, Germany
        • Completed
        • St. Barbara-Klinik Hamm-Heessen
      • Hanover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover MHH
        • Contact:
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Campus Kiel
        • Contact:
      • Mainz, Germany
        • Terminated
        • Johannes Gutenberg Universitaet Mainz
      • Marburg, Germany
        • Recruiting
        • Universitaetsklinikum Giessen und Marburg GmbH
        • Contact:
      • Oldenburg, Germany
        • Withdrawn
        • Evangelisches Krankenhaus Oldenburg
      • Würzburg, Germany
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
  • Hungary
      • Pécs, Hungary
        • Recruiting
        • Medical School of University PECS
        • Contact:
  • Israel
      • Jerusalem, Israel
        • Completed
        • Hadassah Hebrew University Medical Center
  • Italy
      • Ferrara, Italy
        • Completed
        • Azienda Ospedaliero-Universitaria di Ferrara
      • Mestre, Italy
        • Recruiting
        • Ospedale Dell Angelo
        • Contact:
      • Rome, Italy
        • Completed
        • Policlinico Universitario Agostino Gemelli
      • Udine, Italy
        • Terminated
        • Osp. S. Maria Della Misericordia
  • Netherlands
      • The Hague, Netherlands
        • Recruiting
        • Haga Ziekenhuis locatie Leyweg
        • Contact:
  • Poland
      • Bydgoszcz, Poland
        • Terminated
        • 10 Military Clinical Hospital Bydgoszcz
      • Bydgoszcz, Poland
        • Terminated
        • Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz)
      • Gdansk, Poland
        • Terminated
        • Podmiot Leczniczy Copernicus Sp. z o.o.
      • Warsaw, Poland
        • Terminated
        • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
  • Russia
      • Moscow, Russia
        • Terminated
        • National Scientific Center of Neurosurgery N.N. Burdenko
  • South Korea
      • Incheon, South Korea
        • Active, not recruiting
        • St. Mary's Hospital Incheon
  • Spain
      • Barcelona, Spain
        • Completed
        • Hospital Clinic de Barcelona
      • El Palmar, Spain
        • Withdrawn
        • University Hospital Virgen Arrixaca
      • Madrid, Spain
        • Completed
        • Centro Especial Ramon y Cajal
      • Oviedo, Spain
        • Withdrawn
        • Hospital General De Asturias
  • United Kingdom
      • Bristol, United Kingdom
        • Withdrawn
        • Southmead Hospital Bristol
      • Glasgow, United Kingdom
        • Completed
        • Queen Elizabeth University Hospital
      • London, United Kingdom
        • Recruiting
        • Charing Cross Hospital
        • Contact:
      • Newcastle upon Tyne, United Kingdom
        • Recruiting
        • Royal Victoria Infirmary
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with intractable primary and secondary dystonia, for persons 7 years of age and older.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score
Time Frame: up to 3 years
up to 3 years
Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score
Time Frame: up to 3 years
up to 3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in SF-36v2 score after DBS (SF-10v2 in patients under the age of 18 years at the time of consent)
Time Frame: upto 3 years
upto 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Natalie Bloom Lyons, Boston Scientific Neuromodulation Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings