Vercise™ DBS Dystonia Prospective Study

April 8, 2024 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 Backup

Study Locations

  • Belgium
      • Ghent, Belgium
        • Recruiting
        • AZ Sint-Lucas
        • Contact:
  • Germany
      • Berlin, Germany
        • Recruiting
        • University Berlin, Charite Virchow Standort, Wedding
        • Contact:
      • Dusseldorf, 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
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover MHH
        • Contact:
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Campus Kiel
        • Contact:
      • Köln, Germany
        • Recruiting
        • Uniklinik Koln
        • 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        • Withdrawn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
      • Pecs, Hungary
        • Recruiting
        • Medical School of University PECS
        • Contact:
  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Hebrew University Medical Center
        • Contact:
  • Italy
      • Ferrara, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Ferrara
        • Contact:
      • Mestre, Italy
        • Recruiting
        • Ospedale Dell Angelo
        • Contact:
      • Rome, Italy
        • Recruiting
        • Policlinico Universitario Agostino Gemelli
        • Contact:
      • Udine, Italy
        • Terminated
        • Osp. S. Maria Della Misericordia
  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Active, not recruiting
        • St. Mary's Hospital Incheon
  • Netherlands
      • Den Haag, 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
  • Russian Federation
      • Moscow, Russian Federation
        • Suspended
        • National Scientific Center of Neurosurgery N.N. Burdenko
  • 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
        • Recruiting
        • Queen Elizabeth University Hospital
        • Contact:
      • 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

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

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

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

Boston Scientific Corporation

Investigators

  • 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)

March 7, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimated)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

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