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

Essential Tremor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04032470
• Other study ID #: A4080
• Status: Recruiting
• Start date: October 23, 2019
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Stephanie Delvaux
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• Deep Brain Stimulation Systems (DBS)
Subjects receiving DBS implant for treatment of Essential Tremor

Locations

Country	Name	City	State
Belgium	AZ Sint-Lucas	Gent
Belgium	UZ Leuven	Leuven
Belgium	AZ Delta	Roeselare
Canada	Vancouver General Hospital	Vancouver
Germany	Uniklinik Koln	Cologne
Germany	Universitaetsklinikum Dusseldorf	Düsseldorf
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
Hungary	Medical School of University PECS	Pécs
Italy	Policlinico Universitario Agostino Gemelli	Rome
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul ASAN Medical Center	Seoul
Portugal	CHU Sao Joao	Porto
Spain	Hospital De Bellvitge	Barcelona
Spain	Hospital General De Asturias	Oviedo

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  Canada,  Germany,  Hungary,  Italy,  Korea, Republic of,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in tremor scores during the study as compared with baseline as assessed by Fahn-Tolosa- Marin Rating Scale	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
Other	Impression of Change scores during the study using Global Impression of Change	Impression of Change scores during the study using Global Impression of Change	Up to 3 years
Primary	Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST)	Change in quality of life over the course of the study using QUEST	Up to 3 years