Parkinson DiseaseNCT03664609
Deep Brain Stimulation (DBS) Retrospective Outcomes Study
An observational study of Parkinson Disease and Essential Tremor, run by Boston Scientific Corporation at 20 sites in 6 countries.
Trial summary
The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Essential Tremor, Dystonia
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 12 Mar 2019to Dec 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects' chart data will be drawn from the Investigator's standard patient pool treated at his/her practice.
Who may be able to join
- Must be previously treated with or eligible for implantation with a deep brain stimulation system
Who cannot join
- No Exclusion Criteria
Trial locations and contacts
20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 6 countries
United States10 sites, 7 recruiting
- Completed
Albany Medical Center
Albany, New York, 12208
- Completed
St. Luke's Regional Medical Center
Boise, Idaho, 83712
- Recruiting
University of Miami Hospital
Miami, Florida, 33136
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Riverside University Health System
Moreno Valley, California, 26520
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Completed
Swedish Neuroscience Institute
Seattle, Washington, 98122
- Recruiting
University of South Florida
Tampa, Florida, 33612
Boston Scientific Clinical Research Manager, 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
Germany5 sites, 4 recruiting
- Recruiting
Uniklinik Köln
Cologne
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Dusseldorf
Düsseldorf
Boston Scientific Clinical Research, 855-213-9894, BSNClinicalTrials@bsci.com
- Completed
Uniklinikum Jena
Jena
- Recruiting
Universitaetsklinikum Schleswig-Holstein
Lübeck
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
Belgium2 sites, 2 recruiting
- Recruiting
AZ St. Lucas
Ghent
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
AZ Delta
Roeselare
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
France1 site, 1 recruiting
- Recruiting
Hopital Fondation Adolphe de Rothschild
Paris
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Italy1 site, 1 recruiting
- Recruiting
Fondazione Istituto Neurologico Casimiro Mondino
Pavia
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Spain1 site, 1 recruiting
- Recruiting
Hospital Virgen Del Rocio
Seville
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
About this study
The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
Read the detailed description
The purpose of this study is to characterize
- real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia
- Being tested
- Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease | Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System Receives: Device: Deep Brain Stimulation | |
| Essential Tremor | Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System Receives: Device: Deep Brain Stimulation | |
| Dystonia | Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline
Improvement in disease symptoms as assessed by Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline
Measured: 5 yrs. post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start12 Mar 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
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
- NCT03664609
- Sponsor's protocol ID
- A4170
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2018
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation (DBS) Retrospective Outcomes Study
- ClinicalTrials.gov ID
- NCT03664609
- Acronym / sponsor ID
- A4170
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Sep 2018 (actual)
- 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 primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
Detailed description
The purpose of this study is to characterize
- real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | Device: Deep Brain StimulationSubjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System |
| Essential Tremor | – | Device: Deep Brain StimulationSubjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System |
| Dystonia | – | Device: Deep Brain StimulationSubjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects' chart data will be drawn from the Investigator's standard patient pool treated at his/her practice.
Key inclusion criteria (1 listed)
- Must be previously treated with or eligible for implantation with a deep brain stimulation system
Key exclusion criteria (1 listed)
- No Exclusion Criteria
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 StimulationDeep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor. | Device | Dystonia, Essential Tremor, Parkinson's Disease |
Primary outcome
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline
Time frame: 5 yrs. post implant
Improvement in disease symptoms as assessed by Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to 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 7 Oct 2026.
- Individual participant dataSharing planned: No
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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
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Essential Tremor, run by Boston Scientific Corporation at 20 sites in 6 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 1 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 7 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 20 sites in United States, Germany, Belgium, France, Italy and 1 more country. 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 Cleo Mertz (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?
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline (time frame: 5 yrs. post implant). 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 7 Oct 2026.