At a glance
ClinicalIndex Comparison RecordN/ACompleted· 313 enrolled
Drug / intervention
Deep Brain Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Implantable Neurostimulator for the Treatment of Parkinson's Disease
In Brief
A clinical study evaluating Deep Brain Stimulation for Parkinson's Disease. Completed, enrolled 313 participants across 22 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartMay 2013
Primary CompletionDec 2016
Study CompletionDec 2022
TodayJul 2026
First PostedApr 24, 2013
Enrollment StartMay 17, 2013
Primary CompletionDec 27, 2016
Study CompletionDec 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.2 years ago
Interventions
Deep Brain Stimulationdevice
The Vercise™ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.