Trials / Completed
CompletedNCT01839396
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Implantable Neurostimulator for the Treatment of Parkinson's Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 313 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Deep Brain Stimulation | 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. |
Timeline
- Start date
- 2013-05-17
- Primary completion
- 2016-12-27
- Completion
- 2022-12-05
- First posted
- 2013-04-24
- Last updated
- 2023-07-13
- Results posted
- 2018-08-15
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01839396. Inclusion in this directory is not an endorsement.