DystoniaNCT02686125
Vercise™ DBS Dystonia Prospective Study
An observational study of Dystonia, run by Boston Scientific Corporation at 36 sites in 12 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Dystonia
- What is being tested?
- Deep Brain Stimulation (DBS)
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 36 sitesin 12 countries
- Study dates
- 7 Mar 2016to Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with intractable primary and secondary dystonia, for persons 7 years of age and older.
Who may be able to join
- 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.
Who cannot join
- EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.
Trial locations and contacts
36 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 12 countries
Germany12 sites, 9 recruiting
- Recruiting
University Berlin, Charite Virchow Standort, Wedding
Berlin
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Uniklinik Köln
Cologne
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Dusseldorf
Düsseldorf
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Freiburg
Freiburg im Breisgau
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinik Eppendorf
Hamburg
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Completed
St. Barbara-Klinik Hamm-Heessen
Hamm
- Recruiting
Medizinische Hochschule Hannover MHH
Hanover
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitatsklinikum Campus Kiel
Kiel
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Terminated
Johannes Gutenberg Universitaet Mainz
Mainz
- Recruiting
Universitaetsklinikum Giessen und Marburg GmbH
Marburg
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Withdrawn
Evangelisches Krankenhaus Oldenburg
Oldenburg
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Italy4 sites, 1 recruiting
- Completed
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara
- Recruiting
Ospedale Dell Angelo
Mestre
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Completed
Policlinico Universitario Agostino Gemelli
Rome
- Terminated
Osp. S. Maria Della Misericordia
Udine
Poland4 sites
- Terminated
10 Military Clinical Hospital Bydgoszcz
Bydgoszcz
- Terminated
Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz)
Bydgoszcz
- Terminated
Podmiot Leczniczy Copernicus Sp. z o.o.
Gdansk
- Terminated
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warsaw
Spain4 sites
- Completed
Hospital Clinic de Barcelona
Barcelona
- Withdrawn
University Hospital Virgen Arrixaca
El Palmar
- Completed
Centro Especial Ramon y Cajal
Madrid
- Withdrawn
Hospital General De Asturias
Oviedo
United Kingdom4 sites, 2 recruiting
- Withdrawn
Southmead Hospital Bristol
Bristol
- Completed
Queen Elizabeth University Hospital
Glasgow
- Recruiting
Charing Cross Hospital
London
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Belgium2 sites, 1 recruiting
- Terminated
AZ Sint-Lucas
Ghent
- Recruiting
UZ Gasthuisberg
Leuven
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Canada1 site, 1 recruiting
- Recruiting
Queen Elizabeth II Health Sciences Center
Halifax
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Hungary1 site, 1 recruiting
- Recruiting
Medical School of University PECS
Pécs
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Netherlands1 site, 1 recruiting
- Recruiting
Haga Ziekenhuis locatie Leyweg
The Hague
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Russia1 site
- Terminated
National Scientific Center of Neurosurgery N.N. Burdenko
Moscow
South Korea1 site
- Active, not recruiting
St. Mary's Hospital Incheon
Incheon
About this study
Official title: 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.
Read the 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.
- Conditions
- Dystonia
- Being tested
- Deep Brain Stimulation (DBS)
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (DBS)Device
Also called Vercise DBS System Boston Scientific
Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score
Measured: up to 3 years
Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study start7 Mar 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Bloom Lyons, Study director, Boston Scientific Neuromodulation Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686125
- Sponsor's protocol ID
- A4012
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2016
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia
- ClinicalTrials.gov ID
- NCT02686125
- Acronym / sponsor ID
- A4012
- Conditions
- Dystonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with intractable primary and secondary dystonia, for persons 7 years of age and older.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation (DBS)Also: Vercise DBS System Boston ScientificSubjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry. | Device | – |
Primary outcome
Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score
Time frame: up to 3 years
Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalie Bloom Lyons study director
Boston Scientific Neuromodulation Corporation
36 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonia, run by Boston Scientific Corporation at 36 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Germany, Italy, Poland, Spain, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Delvaux (855-213-9890, BSNClinicalTrials@bsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score (time frame: up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.