Health Trials

Vercise™ DBS Dystonia Prospective Study

ConditionDystonia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorBoston Scientific Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

EC1. Meets any contraindication in the Vercise System locally applicable Directions for Use.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Scientific Corporation

Lead sponsor

Source ClinicalTrials.gov
Apply now