ClinicalTrials.gg
RecruitingNCT02686125Updated Oct 13, 2026

Vercise™ DBS Dystonia Prospective Study

An observational study in Dystonia, sponsored by Boston Scientific Corporation. Recruiting at 36 sites in 12 countries. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Boston Scientific Corporation · Observational

From the registry’s dates

  • Started Mar 2016; still recruiting 10 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
7 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dystonia

Browse trials for

03

In context

Dystonia

213 studies on the registry are indexed under Dystonia; 54 are open to participants now.

This study's planned enrollment of 300 is above the median of 78 across 90 observational studies indexed under Dystonia.

Browse Dystonia studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion Criteria (EC):

  • EC1. Meets any in the Vercise System locally applicable Directions for Use.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Interventions

  • DeviceDeep Brain Stimulation (DBS)

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

    Also known as: Vercise DBS System Boston Scientific

06

What researchers measure

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

07

Study locations

16 of 36 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2016 (actual). Primary completion is estimated for Dec 2030, 177 months after the start.

Of 27 observational studies under Dystonia, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 58 and three quarters within 188. This study's planned 177 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2016
First posted
Feb 19, 2016
StartActual
Mar 7, 2016
Primary completionEst.
Dec 2030
CompletionEst.
Dec 2030
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT02686125
Responsible party
Sponsor
First posted
Feb 19, 2016
Start date
Mar 7, 2016
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Oct 13, 2026

Study contacts

Stephanie Delvaux
Contact
BSNClinicalTrials@bsci.com
855-213-9890
Diane Keesey
Contact
BSNClinicalTrials@bsci.com
855-213-9890
Natalie Bloom Lyons
study director · Boston Scientific Neuromodulation Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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