Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)
1 other identifier
observational
500
9 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedStudy Start
First participant enrolled
October 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
March 12, 2026
March 1, 2026
10.1 years
July 8, 2019
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 3 years
Other Outcomes (2)
Change in tremor scores during the study as compared with baseline as assessed by Fahn-Tolosa- Marin Rating Scale
Up to 3 years
Impression of Change scores during the study using Global Impression of Change
Up to 3 years
Study Arms (1)
Essential Tremor
Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems
Interventions
Subjects receiving DBS implant for treatment of Essential Tremor
Eligibility Criteria
Subjects with Essential Tremor
You may qualify if:
- Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor
- Is at least 18 years old
You may not qualify if:
- Meets any contraindication in locally applicable Directions for Use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
A.o. LKH Univ.-Kliniken Innsbruck
Innsbruck, Austria
AZ Sint-Lucas
Ghent, Belgium
UZ Gasthuisberg
Leuven, Belgium
AZ Delta
Roeselare, Belgium
Vancouver General Hospital
Vancouver, Canada
Uniklinik Koln
Cologne, Germany
Universitaetsklinikum Dusseldorf
Düsseldorf, Germany
Universitaetsklinikum Essen
Essen, Germany
Universitatsklinikum Campus Kiel
Kiel, Germany
Universitaetsklinikum Giessen und Marburg GmbH
Marburg, Germany
Evangelisches Krankenhaus Oldenburg
Oldenburg, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Germany
Medical School of University PECS
Pécs, Hungary
Policlinico Universitario Agostino Gemelli
Rome, Italy
CHU Sao Joao
Porto, Portugal
Samsung Medical Center
Seoul, South Korea
Seoul ASAN Medical Center
Seoul, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
Hospital De Bellvitge
Barcelona, 30326, Spain
Hospital General De Asturias
Oviedo, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Natalie Bloom Lyons
Boston Scientific Corporation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2019
First Posted
July 25, 2019
Study Start
October 23, 2019
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
March 12, 2026
Record last verified: 2026-03