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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04032470
• Collaborator: (none)
• Enrollment: 500
• Locations: 12
• Anticipated Duration (Months): 110.3
• Patients Per Site: 41.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Essential Tremor	Device: Deep Brain Stimulation Systems (DBS)

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Boston Scientific Registry of Deep Brain Stimulations for Treatment of Essential Tremor (ET):ET Registry
• Actual Study Start Date: Oct 23, 2019
• Anticipated Primary Completion Date: Dec 31, 2028
• Anticipated Study Completion Date: Dec 31, 2028

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST) [Up to 3 years]

   Change in quality of life over the course of the study using QUEST

Other Outcome Measures

1. Change in tremor scores during the study as compared with baseline as assessed by Fahn-Tolosa- Marin Rating Scale [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

2. Impression of Change scores during the study using Global Impression of Change [Up to 3 years]

   Impression of Change scores during the study using Global Impression of Change

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Sint-Lucas	Gent		Belgium
2	AZ Delta	Roeselare		Belgium
3	Uniklinik Koln	Cologne		Germany
4	Universitatsklinikum Campus Kiel	Kiel		Germany
5	Universitaetsklinikum Wuerzburg	Würzburg		Germany
6	Medical School of University PECS	Pécs		Hungary
7	Policlinico Universitario Agostino Gemelli	Rome		Italy
8	Samsung Medical Center	Seoul		Korea, Republic of
9	Seoul ASAN Medical Center	Seoul		Korea, Republic of
10	CHU Sao Joao	Porto		Portugal
11	Hospital De Bellvitge	Barcelona		Spain	30326
12	Hospital General De Asturias	Oviedo		Spain

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Roshini Jain, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT04032470
• Other Study ID Numbers: A4080
• First Posted: Jul 25, 2019
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• 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
• Keywords provided by Boston Scientific Corporation: Deep Brain Stimulation; Boston Scientific; Essential Tremor
• Additional relevant MeSH terms: Tremor; Essential Tremor

Study Results

No Results Posted as of Aug 10, 2022