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NCT Number: NCT04032470

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

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.o. LKH Univ.-Kliniken Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Brain Stimulation Systems (DBS)

Device

Subjects receiving DBS implant for treatment of Essential Tremor

Primary outcomes

  1. 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

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

Other outcomes

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

    Time frame: 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

    Time frame: Up to 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Keesey

CONTACT

[email protected]

855-213-9890

Stephanie Delvaux

CONTACT

[email protected]

855-213-9890

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Jul 25, 2019
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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