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Registry of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia: Vercise DBS Dystonia Registry

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ClinicalTrials.gov Identifier: NCT02686125
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment
Dystonia Device: Deep Brain Stimulation (DBS)

Detailed Description:

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Registry of Deep Brain Stimulation With the VERCISE™ System for Treatment of Dystonia: Vercise DBS Dystonia Registry
Study Start Date : March 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia


Intervention Details:
  • Device: Deep Brain Stimulation (DBS)
    Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry.
    Other Name: Vercise DBS System Boston Scientific


Primary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with intractable primary and secondary dystonia, for persons 7 years of age and older.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686125


Contacts
Contact: Nic Van Dyck VanDycKN@bsci.com

Locations
United States, California
Boston Scientific Clinical Research Information Recruiting
Valencia, California, United States, 91355
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Nic Van Dyck Boston Scientific Corporation

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02686125     History of Changes
Other Study ID Numbers: A4012
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases