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Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

ConditionParkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.

The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.

Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meets criteria established in locally applicable Vercise System Direction for Use

At least 18 years old

Disqualifiers

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

Trial population

Patients with symptoms of Parkinson's disease that are not adequately controlled with medication

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 Parkinson's disease symptoms will be offered participation in this registry.

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Parkinson's disease1 intervention

Trial outcomes

Primary outcomes

1

Improvement in patient's quality of life (QoL) during the study as compared with baseline

Change in quality of life assessments during the study as compared with baseline

Time frame
up to 3 years

Secondary outcomes

Other outcomes

1

Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline

Change in patient's motor symptoms as determined by UPDRS during the study as compared with baseline

Time frame
up to 3 years
2

Change in medication usage during the study as compared with baseline

Time frame
up to 3 years
3

Impression of change scores during the study as compared with baseline

Impression of change scores during the study as compared with baseline

Time frame
3 years

Sponsors and contacts

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

Boston Scientific Corporation

Lead sponsor

Source ClinicalTrials.gov
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