Parkinson's DiseaseNCT02071134

Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

An observational study of Parkinson's Disease, run by Boston Scientific Corporation at 87 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: Deep Brain Stimulation (DBS)
Type of treatment: Medical device
How many people: 1,500 participants
Where: 87 sitesin 15 countries
Study dates: 4 Mar 2014to Dec 2038
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with symptoms of Parkinson's disease that are not adequately controlled with medication

Who may be able to join

Meets criteria established in locally applicable Vercise System Direction for Use
At least 18 years old

Who cannot join

Meets any contraindication in the Vercise System locally applicable Directions for Use
Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.

Trial locations and contacts

87 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Heleen Scholtes contact

855-213-9890

BSNClinicalTrials@bsci.com

Alison Lewis contact

855-213-9890

BSNClinicalTrials@bsci.com

Country

City, postcode or hospital

Sites recruiting now only

87 sites in 15 countries

United States29 sites, 19 recruiting

Albany Medical College
Albany, New York, 12208
Completed
Neurology and Pain Specialty
Aliso Viejo, California, 92656
Withdrawn
University of Colorado
Aurora, Colorado, 80220
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
St. Luke Regional Medical Center
Boise, Idaho, 83702
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Withdrawn
University of Virginia Medical Center
Charlottesville, Virginia, 22903
Withdrawn
Rush University Medical Center
Chicago, Illinois, 60612
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Terminated
Ohio State University
Columbus, Ohio, 43210
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
University of Florida Shands Hospital
Gainesville, Florida, 32610
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81501
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Northwell Health Neuroscience Institute
Great Neck, New York, 11021
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Methodist Hospital of Indianapolis
Indianapolis, Indiana, 46202
Completed
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
Withdrawn
Evergreen Health
Kirkland, Washington, 98034
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
University of Miami Hospital
Miami, Florida, 33136
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
Withdrawn
University of Texas Health Medical Arts and Research Center
San Antonio, Texas, 78229
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Texas Institute for Neurological Disorders
Sherman, Texas, 75092
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Inland Northwest Research
Spokane, Washington, 99202
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
St. Louis University Hospital
St Louis, Missouri, 63110
Withdrawn
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, 32308
Withdrawn
University of South Florida
Tampa, Florida, 33612
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
University at Buffalo
Williamsville, New York, 14221
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting

Other trials in United States

Germany12 sites, 8 recruiting

University Berlin, Charite Virchow Standort, Wedding
Berlin
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Uniklinik Köln
Cologne
Completed
Universitätsklinikum Düsseldorf
Düsseldorf
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau
Active, not recruiting
Universitätsklinik Eppendorf
Hamburg
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
St. Barbara-Klinik Hamm-Heessen
Hamm
Withdrawn
Universitätsklinikum Campus Kiel
Kiel
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Johannes Gutenberg Universitaet Mainz
Mainz
Withdrawn
Universitaetsklinikum Giessen und Marburg GmbH
Marburg
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Evangelisches Krankenhaus Oldenburg
Oldenburg
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Universitaetsklinikum Tuebingen
Tübingen
Boston Scientific Clinical Research, 855-213-9890
BSNClinicalTrials@bsci.com
Recruiting
Universitätsklinikum Würzburg
Würzburg
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting

Other trials in Germany

United Kingdom8 sites, 1 recruiting

Southmead Hospital Bristol
Bristol
Completed
Queen Elizabeth University Hospital
Glasgow
Active, not recruiting
The Walton Centre
Liverpool
Completed
Charing Cross Hospital
London
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
King's College Hospital London
London
Completed
St. Georges Hospital
London
Completed
Royal Victoria Infirmary
Newcastle
Active, not recruiting
John Radcliffe Hospital
Oxford
Completed

Other trials in United Kingdom

Italy7 sites, 1 recruiting

Villa Margherita
Arcugnano
Terminated
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara
Completed
Ospedale Dell Angelo
Mestre
Terminated
IRCCS Istituto Ortopedico Galeazzi
Milan
Terminated
Fondazione Istituto Neurologico Casimiro Mondino
Pavia
Completed
Policlinico Universitario Agostino Gemelli
Rome
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Osp. S. Maria Della Misericordia
Udine
Terminated

Other trials in Italy

Spain7 sites, 2 recruiting

Hospital Clinic de Barcelona
Barcelona
Completed
Hospital De Bellvitge
Barcelona
Active, not recruiting
Centro Especial Ramon y Cajal
Madrid
Completed
Hospital Clinico San Carlos
Madrid
Completed
University Hospital Virgen Arrixaca
Murcia
Withdrawn
Hospital General De Asturias
Oviedo
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Hospital Universitario La Fe
Valencia
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting

Other trials in Spain

France5 sites

CHU Henri Mondor
Créteil
Active, not recruiting
Hopital Neurologique Pierre Wertheimer
Lyon
Completed
CHU La Timone Hospital
Marseille
Active, not recruiting
Fondation Ophtalmologique Adolphe de Rothschild
Paris
Terminated
CHRU Hopital Pontchaillou
Rennes
Withdrawn

Other trials in France

Belgium3 sites

AZ Sint-Lucas
Ghent
Active, not recruiting
UZ Gasthuisberg
Leuven
Active, not recruiting
AZ Delta
Roeselare
Active, not recruiting

Other trials in Belgium

Israel3 sites

Hadassah Hebrew University Medical Center
Jerusalem
Active, not recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Completed
Sheba Medical Center
Tel HaShomer
Completed

Other trials in Israel

Poland3 sites

10 Military Clinical Hospital Bydgoszcz
Bydgoszcz
Terminated
Podmiot Leczniczy Copernicus Sp. z o.o.
Gdansk
Completed
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
Warsaw
Terminated

Other trials in Poland

South Korea3 sites

Samsung Medical Center
Seoul
Active, not recruiting
Seoul ASAN Medical Center
Seoul
Terminated
Yonsei University Severance Hospital
Seoul
Completed

Other trials in South Korea

Canada2 sites

Queen Elizabeth II Health Sciences Center
Halifax
Active, not recruiting
Hopital de Enfant-Jesus
Québec
Active, not recruiting

Other trials in Canada

Turkey (Türkiye)2 sites, 2 recruiting

Bahcesehir University Hospital Medical Park Goztepe
Istanbul
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting
Koc University Hospital
Istanbul
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting

Other trials in Turkey (Türkiye)

Argentina1 site, 1 recruiting

Fundacion Ineco-Research Facility
Buenos Aires
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting

Other trials in Argentina

Austria1 site, 1 recruiting

A.o. LKH Univ.-Kliniken Innsbruck
Innsbruck
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Recruiting

Other trials in Austria

Hungary1 site

Medical School of University PECS
Pécs
Active, not recruiting

Other trials in Hungary

About this study

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.

The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.

Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.

Read the detailed description

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.

Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated.

Conditions: Parkinson's Disease
Being tested: Deep Brain Stimulation (DBS)
Keywords: Deep brain stimulation, Parkinson's disease, Vercise
Medical subject headings: Parkinson Disease

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 Parkinson's disease symptoms will be offered participation in this registry.

Study groups in NCT02071134
Study group	Role	What they receive
Parkinson's disease		Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation. Receives: Device: Deep Brain Stimulation (DBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in patient's quality of life (QoL) during the study as compared with baseline
Change in quality of life assessments during the study as compared with baseline
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.

4 Mar 2014Dec 2038

First posted25 Feb 2014 (estimated)
Study start4 Mar 2014
Primary completionDec 2038 (estimated)
Study completionDec 2038 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies 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: 1,500 participants (estimated)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02071134
Sponsor's protocol ID: A4010
Other IDs: A4069
Status last verified: Oct 2026
First submitted: 21 Feb 2014
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Interested in taking part?

Heleen Scholtes

855-213-9890

BSNClinicalTrials@bsci.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinson's Disease trials

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: Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
ClinicalTrials.gov ID: NCT02071134
Acronym / sponsor ID: A4010
Conditions: Parkinson's Disease
Keywords: Deep brain stimulation, Parkinson's disease, Vercise
Study type: Observational
Recruitment status: Recruiting
Enrolment: 1,500 participants (estimated)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 4 Mar 2014 (actual)
Primary completion: Dec 2038 (estimated)
Study completion: Dec 2038 (estimated)
First posted: 25 Feb 2014 (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.

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.

Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.

Detailed description

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 1

Arm	Type	Receives
Parkinson's disease	–	Device: Deep Brain Stimulation (DBS)Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with symptoms of Parkinson's disease that are not adequately controlled with medication

Key inclusion criteria (2 listed)

Meets criteria established in locally applicable Vercise System Direction for Use
At least 18 years old

Key exclusion criteria (2 listed)

Meets any contraindication in the Vercise System locally applicable Directions for Use
Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.

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 Parkinson's disease symptoms will be offered participation in this registry.	Device	Parkinson's disease

Primary outcome

Improvement in patient's quality of life (QoL) during the study as compared with baseline
Time frame: up to 3 years
Change in quality of life assessments during the study as compared with baseline

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.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

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.

Heleen Scholtes contact

855-213-9890

BSNClinicalTrials@bsci.com

Alison Lewis contact

855-213-9890

BSNClinicalTrials@bsci.com

Natalie Bloom Lyons study director

Boston Scientific Neuromodulation Corporation

87 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by Boston Scientific Corporation at 87 sites in 15 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 2 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 87 sites in United States, Germany, United Kingdom, Italy, Spain and 10 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 Heleen Scholtes (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?

Improvement in patient's quality of life (QoL) during the study as compared with baseline (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02071134.

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.