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ClinicalTrials.gov ID

NCT02686125

Lead Sponsor

Boston Scientific CorporationINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Aug 6, 2026Actual

Start Date

Mar 7, 2016Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

Official Title

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

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.

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.

• Dystonia

• Deep Brain Stimulation (DBS)

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Boston Scientific CorporationINDUSTRY

BSNClinicalTrials@bsci.com855-213-9890