Recruiting

Vercise™ DBS

Sponsor:

Boston Scientific Corporation

Code:

NCT02686125

Conditions

Dystonia

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation (DBS)

Study Details

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.

Conditions

Dystonia

Study ID

NCT02686125

Start date

Mar 7, 2016

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

Deep Brain Stimulation (DBS)

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

Primary outcome measure

  • Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score [ Time Frame: up to 3 years ]
  • Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score [ Time Frame: up to 3 years ]

Central Contacts and Locations

Central contacts

Stephanie Delvaux

855-213-9890BSNClinicalTrials@bsci.com

Diane Keesey

855-213-9890BSNClinicalTrials@bsci.com

Locations

Queen Elizabeth II Health Sciences Center

Recruiting

Halifax, Canada

Contacts

Boston Scientific Clinical Research

855-213-9890BSNClinicalTrials@bsci.com

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-08-06.