Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)

NCT ID: NCT04032470

Last Updated: 2026-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-23

Study Completion Date

2029-12-31

Brief Summary

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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

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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

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Essential Tremor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Essential Tremor

Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems

Deep Brain Stimulation Systems (DBS)

Intervention Type DEVICE

Subjects receiving DBS implant for treatment of Essential Tremor

Interventions

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Deep Brain Stimulation Systems (DBS)

Subjects receiving DBS implant for treatment of Essential Tremor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor
* Is at least 18 years old

Exclusion Criteria

* Meets any contraindication in locally applicable Directions for Use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalie Bloom Lyons

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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A.o. LKH Univ.-Kliniken Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

AZ Sint-Lucas

Ghent, , Belgium

Site Status RECRUITING

UZ Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Vancouver General Hospital

Vancouver, , Canada

Site Status RECRUITING

Uniklinik Koln

Cologne, , Germany

Site Status RECRUITING

Universitaetsklinikum Dusseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Universitaetsklinikum Essen

Essen, , Germany

Site Status RECRUITING

Universitatsklinikum Campus Kiel

Kiel, , Germany

Site Status RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Oldenburg

Oldenburg, , Germany

Site Status RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status RECRUITING

Medical School of University PECS

Pécs, , Hungary

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, , Italy

Site Status WITHDRAWN

CHU Sao Joao

Porto, , Portugal

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul ASAN Medical Center

Seoul, , South Korea

Site Status WITHDRAWN

Yonsei University Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Hospital De Bellvitge

Barcelona, , Spain

Site Status RECRUITING

Hospital General De Asturias

Oviedo, , Spain

Site Status RECRUITING

Countries

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Austria Belgium Canada Germany Hungary Italy Portugal South Korea Spain

Central Contacts

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Stephanie Delvaux

Role: CONTACT

855-213-9890

Diane Keesey

Role: CONTACT

855-213-9890

Facility Contacts

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Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research Manager

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Boston Scientific Clinical Research

Role: primary

855-213-9890

Other Identifiers

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A4080

Identifier Type: -

Identifier Source: org_study_id

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