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

Recruiting

• Conditions: Essential Tremor
• Interventions: Device: Deep Brain Stimulation Systems (DBS)

• Registration Number: NCT04032470
• Lead Sponsor: Boston Scientific Corporation

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.

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 Timeline

• Study First Submitted: 2019-07-08
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-25
• Study Start: 2019-10-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Essential Tremor	Deep Brain Stimulation Systems (DBS)	Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST)	Up to 3 years	Change in quality of life over the course of the study using QUEST

Trial Locations

Locations (19)

AZ Sint-Lucas; 🇧🇪 Gent, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

Vancouver General Hospital; 🇨🇦 Vancouver, Canada

Uniklinik Koln; 🇩🇪 Cologne, 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

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Universitaetsklinikum Dusseldorf; 🇩🇪 Düsseldorf, Germany

Seoul ASAN Medical Center; 🇰🇷 Seoul, Korea, Republic of

Hospital De Bellvitge; 🇪🇸 Barcelona, Spain

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

CHU Sao Joao; 🇵🇹 Porto, Portugal

Hospital General De Asturias; 🇪🇸 Oviedo, Spain