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NCT Number: NCT02686125

Vercise™ DBS Dystonia Prospective Study

To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.

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Key information

Conditions

Dystonia Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Sint-Lucas, Ghent, Belgium

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About this study

To compile characteristics of real-world outcomes of Boston Scientific Corporation's commercially approved VerciseTM Deep Brain Stimulation (DBS) Systems for the treatment of dystonia.

Subjects' improvement in disease symptoms and overall Quality of life will be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(IC):

  • IC1. Meets criteria established in the locally applicable Vercise System Directions for Use (DFU) for dystonia.
  • IC2. At least 7 years old. Parent or guardian consent is required in patients who are younger than 18 years at the time of consent.

Exclusion criteria

(EC):

  • EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.

Treatment and study plan

Deep Brain Stimulation (DBS)

Device

Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry.

Other names: Vercise DBS System Boston Scientific

Primary outcomes

  1. Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score

    Time frame: up to 3 years

  2. Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score

    Time frame: up to 3 years

Other outcomes

  1. Change in SF-36v2 score after DBS (SF-10v2 in patients under the age of 18 years at the time of consent)

    Time frame: upto 3 years

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Prospective Study of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Feb 19, 2016
Registry last updated
Sep 11, 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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