Clinical trial NCT04032470: Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)
Official title: Boston Scientific Registry of Deep Brain Stimulations for Treatment of Essential Tremor (ET):ET Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Essential Tremor
Keywords: Deep Brain Stimulation
Boston Scientific
Essential Tremor
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Essential Tremor

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.

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

Primary outcomes:
measure: Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST)
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
measure: Change in tremor scores during the study as compared with baseline as assessed by Fahn-Tolosa- Marin Rating Scale
timeFrame: Up to 3 years
measure: Impression of Change scores during the study using Global Impression of Change
timeFrame: Up to 3 years
Locations:
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Roeselare
country: Belgium
facility: AZ Delta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
city: Cologne
country: Germany
facility: Uniklinik Koln
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Dusseldorf
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Kiel
country: Germany
facility: Universitatsklinikum Campus Kiel
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus Oldenburg
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Pécs
country: Hungary
facility: Medical School of University PECS
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul ASAN Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Porto
country: Portugal
facility: CHU Sao Joao
city: Barcelona
country: Spain
facility: Hospital De Bellvitge
city: Oviedo
country: Spain
facility: Hospital General De Asturias
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: