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NCT04032470 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 23, 2019
Est. completion date December 2028

Study information
Verified date April 2024
Source Boston Scientific Corporation
Contact Stephanie Delvaux
Phone 855-213-9890
Email BSNClinicalTrials@bsci.com
Is FDA regulated No
Health authority
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
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

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 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
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Terminated NCT02678429 - Atlas Predicted DBS Settings in Essential Tremor N/A
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Completed NCT02523807 - Tremor Monitoring Device N/A
Active, not recruiting NCT02255929 - Gamma Knife Radiosurgery for Treatment of Essential Tremor N/A
Completed NCT01223144 - Decision-making and Emotion Recognition in Essential Tremor N/A
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Completed NCT03051178 - Wearable Sensor for Responsive DBS for ET N/A
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Recruiting NCT05968976 - Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET N/A
Completed NCT06314139 - Tolerability and Efficacy of Continuous Theta-burst Stimulation for Essential Tremor: A Randomized Study. N/A
Recruiting NCT04501133 - Sensory-specific Peripheral Stimulation for Tremor Management N/A
Active, not recruiting NCT03560622 - Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy N/A
Completed NCT00368199 - Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes N/A
Completed NCT05106816 - The Effects of Vibrotactile Stimulation in Patients With Movement Disorders N/A