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

April 5, 2024 updated by: Boston Scientific Corporation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Gent, Belgium
        • Recruiting
        • AZ Sint-Lucas
        • Contact:
      • Roeselare, Belgium
        • Recruiting
        • AZ Delta
        • Contact:
  • Canada
      • Vancouver, Canada
        • Recruiting
        • Vancouver General Hospital
        • Contact:
  • Germany
      • Cologne, Germany
        • Recruiting
        • Uniklinik Köln
        • Contact:
      • Düsseldorf, Germany
        • Recruiting
        • Universitaetsklinikum Dusseldorf
        • Contact:
      • Essen, Germany
        • Recruiting
        • Universitaetsklinikum Essen
        • Contact:
      • Kiel, Germany
        • Recruiting
        • Universitätsklinikum Campus Kiel
        • Contact:
      • Marburg, Germany
        • Recruiting
        • Universitaetsklinikum Giessen und Marburg GmbH
        • Contact:
      • Oldenburg, Germany
        • Recruiting
        • Evangelisches Krankenhaus Oldenburg
        • Contact:
      • Würzburg, Germany
        • Recruiting
        • Universitaetsklinikum Wuerzburg
        • Contact:
  • Hungary
      • Pécs, Hungary
        • Recruiting
        • Medical School of University PECS
        • Contact:
  • Italy
      • Rome, Italy
        • Withdrawn
        • Policlinico Universitario Agostino Gemelli
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Withdrawn
        • Seoul ASAN Medical Center
  • Portugal
      • Porto, Portugal
        • Recruiting
        • CHU Sao Joao
        • Contact:
  • Spain
      • Barcelona, Spain, 30326
        • Recruiting
        • Hospital de Bellvitge
        • Contact:
      • Oviedo, Spain
        • Recruiting
        • Hospital General De Asturias
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects with Essential Tremor

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Essential Tremor
Subjects with Essential Tremor being implanted with Boston Scientific Deep Brain Stimulation Systems
Device: Deep Brain Stimulation Systems (DBS)
Subjects receiving DBS implant for treatment of Essential Tremor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tremor scores during the study as compared with baseline as assessed by Fahn-Tolosa- Marin Rating Scale
Time Frame: Up to 3 years
Improvement in tremor scores as assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) during the study as compared with baseline
Up to 3 years
Impression of Change scores during the study using Global Impression of Change
Time Frame: Up to 3 years
Impression of Change scores during the study using Global Impression of Change
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 25, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4080

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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