Essential TremorNCT04032470
Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)
An observational study of Essential Tremor, run by Boston Scientific Corporation at 20 sites in 9 countries.
Trial summary
To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Deep Brain Stimulation Systems (DBS)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 20 sitesin 9 countries
- Study dates
- 23 Oct 2019to Dec 2039
- 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
- Adult, Older adult
Study population: Subjects with Essential Tremor
Who may be able to join
- Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor
- Is at least 18 years old
Who cannot join
- Meets any contraindication in locally applicable Directions for Use
Trial locations and contacts
20 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 9 countries
Germany7 sites, 7 recruiting
- Recruiting
Uniklinik Koln
Cologne
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Dusseldorf
Düsseldorf
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Essen
Essen
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitatsklinikum Campus Kiel
Kiel
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Giessen und Marburg GmbH
Marburg
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Evangelisches Krankenhaus Oldenburg
Oldenburg
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Belgium3 sites, 3 recruiting
- Recruiting
AZ Sint-Lucas
Ghent
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
UZ Gasthuisberg
Leuven
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
AZ Delta
Roeselare
Boston Scientific Clinical Research Manager, 855-213-9890, BSNClinicalTrials@bsci.com
South Korea3 sites, 2 recruiting
- Recruiting
Samsung Medical Center
Seoul
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Withdrawn
Seoul ASAN Medical Center
Seoul
- Recruiting
Yonsei University Severance Hospital
Seoul
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital De Bellvitge
Barcelona, 30326
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
- Recruiting
Hospital General De Asturias
Oviedo
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Austria1 site, 1 recruiting
- Recruiting
A.o. LKH Univ.-Kliniken Innsbruck
Innsbruck
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver
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
Portugal1 site, 1 recruiting
- Recruiting
CHU Sao Joao
Porto
Boston Scientific Clinical Research, 855-213-9890, BSNClinicalTrials@bsci.com
About this study
Official title: Boston Scientific Registry of Deep Brain Stimulations for Treatment of Essential Tremor (ET):ET Registry
To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor.
Read the detailed description
To compile characteristics of real-world outcomes using Deep Brain Stimulation (DBS) for the treatment of Essential Tremor to add to the evidence available for treatment of ET.
- Conditions
- Essential Tremor
- Being tested
- Deep Brain Stimulation Systems (DBS)
- Keywords
- Deep Brain Stimulation, Boston Scientific, Essential Tremor
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation Systems (DBS)Device
Subjects receiving DBS implant for treatment of Essential Tremor
| Study group | Role | What they receive |
|---|---|---|
| Essential Tremor | Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems Receives: Device: Deep Brain Stimulation Systems (DBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST)
Change in quality of life over the course of the study using QUEST
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 posted25 Jul 2019
- Study start23 Oct 2019
- Primary completionDec 2039 (estimated)
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies 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
- 500 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 Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032470
- Sponsor's protocol ID
- A4080
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Boston Scientific Registry of Deep Brain Stimulations for Treatment of Essential Tremor (ET):ET Registry
- ClinicalTrials.gov ID
- NCT04032470
- Acronym / sponsor ID
- A4080
- Conditions
- Essential Tremor
- Keywords
- Deep Brain Stimulation, Boston Scientific, Essential Tremor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- Dec 2039 (estimated)
- Study completion
- Dec 2039 (estimated)
- First posted
- 25 Jul 2019 (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.
To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor.
Detailed description
To compile characteristics of real-world outcomes using Deep Brain Stimulation (DBS) for the treatment of Essential Tremor to add to the evidence available for treatment of ET.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Essential Tremor | – | Device: Deep Brain Stimulation Systems (DBS)Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with Essential Tremor
Key inclusion criteria (2 listed)
- Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor
- Is at least 18 years old
Key exclusion criteria (1 listed)
- Meets any contraindication in 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 Systems (DBS)Subjects receiving DBS implant for treatment of Essential Tremor | Device | Essential Tremor |
Primary outcome
Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST)
Time frame: Up to 3 years
Change in quality of life over the course of the study using QUEST
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 Corporation
20 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor, run by Boston Scientific Corporation at 20 sites in 9 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 20 sites in Germany, Belgium, South Korea, Spain, Austria and 4 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?
Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST) (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?
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.