Deep Brain Stimulation (DBS) Retrospective Outcomes Study
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Boston Scientific Corporation
- Study ID
- NCT03664609
- Status
- Recruiting
Conditions
- Dystonia
- Essential Tremor
- Parkinson Disease
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Deep Brain Stimulation — DEVICEDeep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.
Study Details
The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
Key Dates
- Start date
- Mar 12, 2019
- Status verified
- May 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 5,000 participants (estimated)
Arms
- Arm: Parkinson's DiseaseSubjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System
- Arm: Essential TremorSubjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System
- Arm: DystoniaSubjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System
Primary Outcome Measure
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline [ Time Frame: 5 yrs. post implant ]
Central Contacts
- Cleo Mertz855-213-9890
- Diane Keesey855-213-9890
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| St. Joseph's Hospital & Medical Center | Phoenix | Arizona | 85013 | |
| University of California, San Francisco | San Francisco | California | 94143 | |
| University of Miami Hospital | Miami | Florida | 33136 | |
| University of South Florida | Tampa | Florida | 33612 | |
| St. Luke's Regional Medical Center | Boise | Idaho | 83712 | |
| Albany Medical Center | Albany | New York | 12208 | |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | - |
Find similar trials in Phoenix, AZ
By condition
By specialty
Related Studies
- Natural History Study of SynucleinopathiesRecruiting · NYU Langone Health · Boston, Massachusetts
- Effects of Stimulation Patterns of Deep Brain StimulationEnrolling By Invitation · Duke University · Gainesville, Florida
- North American Prodromal Synucleinopathy ConsortiumEnrolling By Invitation · Washington University School of Medicine · Sun City, Arizona
- Closed Loop DBS Implanted RC+S StudyEnrolling By Invitation · Dennis Turner, M.D. · Durham, North Carolina