Vercise™ DBS Dystonia Prospective Study | NCT02686125

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2016Actual

Primary Completion Date

Dec 2030Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Feb 10, 2016

First Submission Date that Met QC Criteria

Feb 16, 2016

First Posted Date

Feb 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.		Vercise DBS System Boston Scientific

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects with reduction in dystonia symptoms as assessed by BFMDRS score		up to 3 years
Proportion of cervical dystonia subjects with reduction in symptoms as assessed by TWSTRS score		up to 3 years

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Change in SF-36v2 score after DBS (SF-10v2 in patients under the age of 18 years at the time of consent)		upto 3 years

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects with intractable primary and secondary dystonia, for persons 7 years of age and older.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephanie Delvaux	Contact	855-213-9890		BSNClinicalTrials@bsci.com
Diane Keesey	Contact	855-213-9890		BSNClinicalTrials@bsci.com

Overall Officials

Name	Affiliation	Role
Natalie Bloom Lyons	Boston Scientific Neuromodulation Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AZ Sint-Lucas	Terminated	Ghent			Belgium
UZ Gasthuisberg

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D013514	Surgical Procedures, Operative