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Brain pacemaker tested for dystonia relief

NCT ID NCT02686125

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 8 times

Summary

This study is tracking how well the VERCISE™ deep brain stimulation (DBS) system works for people with dystonia, a movement disorder causing muscle spasms. Researchers will follow 300 participants aged 7 and older who are already receiving DBS to see if their symptoms improve. The goal is to gather real-world evidence on the device's effectiveness and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
deep brain stimulation (DBS) device
What this could lead to
If successful, this could confirm that DBS with the VERCISE™ system is a safe and effective way to reduce dystonia symptoms in everyday medical practice.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. DBS involves brain surgery, which carries risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2016

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

7 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Dystonia dystonic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dystonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • 10 Military Clinical Hospital Bydgoszcz

    TERMINATED

    Bydgoszcz, Poland

  • AZ Sint-Lucas

    TERMINATED

    Ghent, Belgium

  • Azienda Ospedaliero-Universitaria di Ferrara

    COMPLETED

    Ferrara, Italy

  • Centro Especial Ramon y Cajal

    COMPLETED

    Madrid, Spain

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    TERMINATED

    Warsaw, Poland

  • Charing Cross Hospital

    RECRUITING

    London, United Kingdom

  • Evangelisches Krankenhaus Oldenburg

    WITHDRAWN

    Oldenburg, Germany

  • Hadassah Hebrew University Medical Center

    COMPLETED

    Jerusalem, Israel

  • Haga Ziekenhuis locatie Leyweg

    RECRUITING

    The Hague, Netherlands

  • Hospital Clinic de Barcelona

    COMPLETED

    Barcelona, Spain

  • Hospital General De Asturias

    WITHDRAWN

    Oviedo, Spain

  • Johannes Gutenberg Universitaet Mainz

    TERMINATED

    Mainz, Germany

  • Medical School of University PECS

    RECRUITING

    Pécs, Hungary

  • Medizinische Hochschule Hannover MHH

    RECRUITING

    Hanover, Germany

  • National Scientific Center of Neurosurgery N.N. Burdenko

    TERMINATED

    Moscow, Russia

  • Osp. S. Maria Della Misericordia

    TERMINATED

    Udine, Italy

  • Ospedale Dell Angelo

    RECRUITING

    Mestre, Italy

  • Podmiot Leczniczy Copernicus Sp. z o.o.

    TERMINATED

    Gdansk, Poland

  • Policlinico Universitario Agostino Gemelli

    COMPLETED

    Rome, Italy

  • Queen Elizabeth II Health Sciences Center

    RECRUITING

    Halifax, Canada

  • Queen Elizabeth University Hospital

    COMPLETED

    Glasgow, United Kingdom

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Southmead Hospital Bristol

    WITHDRAWN

    Bristol, United Kingdom

  • St. Barbara-Klinik Hamm-Heessen

    COMPLETED

    Hamm, Germany

  • St. Mary's Hospital Incheon

    ACTIVE_NOT_RECRUITING

    Incheon, South Korea

  • UZ Gasthuisberg

    RECRUITING

    Leuven, Belgium

  • Uniklinik Köln

    RECRUITING

    Cologne, Germany

  • Universitaetsklinik Eppendorf

    RECRUITING

    Hamburg, Germany

  • Universitaetsklinikum Dusseldorf

    RECRUITING

    Düsseldorf, Germany

  • Universitaetsklinikum Freiburg

    RECRUITING

    Freiburg im Breisgau, Germany

  • Universitaetsklinikum Giessen und Marburg GmbH

    RECRUITING

    Marburg, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, Germany

  • Universitatsklinikum Campus Kiel

    RECRUITING

    Kiel, Germany

  • University Berlin, Charite Virchow Standort, Wedding

    RECRUITING

    Berlin, Germany

  • University Hospital Virgen Arrixaca

    WITHDRAWN

    El Palmar, Spain

  • Wojewodzki Szpital Dzieciecy Jozefa Brudzinskiego (Childrens Hospital Bydgoszcz)

    TERMINATED

    Bydgoszcz, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.