Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep Brain Stimulation Systems (DBS).
- Who it may be relevant to
- Registry conditions: Essential Tremor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, Canada, Germany, Hungary +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Boston Scientific Registry of Deep Brain Stimulations for Treatment of Essential Tremor (ET):ET Registry
Overview
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.
Interventions
- Device Deep Brain Stimulation Systems (DBS)
Subjects receiving DBS implant for treatment of Essential Tremor
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 7 centers
- Uniklinik Koln — Cologne
- Universitaetsklinikum Dusseldorf — Düsseldorf
- Universitaetsklinikum Essen — Essen
- Universitatsklinikum Campus Kiel — Kiel
- Universitaetsklinikum Giessen und Marburg GmbH — Marburg
- Evangelisches Krankenhaus Oldenburg — Oldenburg
- Universitaetsklinikum Wuerzburg — Würzburg
Belgium · 3 centers
- AZ Sint-Lucas — Ghent
- UZ Gasthuisberg — Leuven
- AZ Delta — Roeselare
South Korea · 3 centers
- Samsung Medical Center — Seoul
- Seoul ASAN Medical Center — Seoul
- Yonsei University Severance Hospital — Seoul
Spain · 2 centers
- Hospital De Bellvitge — Barcelona
- Hospital General De Asturias — Oviedo
Austria · 1 center
- A.o. LKH Univ.-Kliniken Innsbruck — Innsbruck
Canada · 1 center
- Vancouver General Hospital — Vancouver
Hungary · 1 center
- Medical School of University PECS — Pécs
Italy · 1 center
- Policlinico Universitario Agostino Gemelli — Rome
Portugal · 1 center
- CHU Sao Joao — Porto
Identifiers
NCT: NCT04032470 · A4080