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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.
The purpose of this study is to characterize
1. real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease | Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System |
| |
| Essential Tremor | Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System |
| |
| Dystonia | Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline | Improvement in disease symptoms as assessed by Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline | 5 yrs. post implant |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects' chart data will be drawn from the Investigator's standard patient pool treated at his/her practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cleo Mertz | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com | |
| Diane Keesey | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Neuromodulation Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital & Medical Center | Recruiting | Phoenix | Arizona | 85013 | United States |
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| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
|
| University of Miami Hospital | Recruiting | Miami | Florida | 33136 | United States |
|
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
|
| St. Luke's Regional Medical Center | Recruiting | Boise | Idaho | 83712 | United States |
|
| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
|
| Wake Forest University School of Medicine | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
|
| Swedish Neuroscience Institute | Completed | Seattle | Washington | 98122 | United States |
| AZ St. Lucas | Recruiting | Ghent | Belgium |
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| AZ Delta | Recruiting | Roeselare | Belgium |
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| Hopital Fondation Adolphe de Rothschild | Recruiting | Paris | France |
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| Uniklinik Köln | Recruiting | Cologne | Germany |
|
| Universitaetsklinikum Dusseldorf | Recruiting | Düsseldorf | Germany |
|
| Uniklinikum Jena | Completed | Jena | Germany |
| Universitaetsklinikum Schleswig-Holstein | Recruiting | Lübeck | Germany |
|
| Universitaetsklinikum Wuerzburg | Recruiting | Würzburg | Germany |
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| Fondazione Istituto Neurologico Casimiro Mondino | Recruiting | Pavia | Italy |
|
| Hospital Virgen Del Rocio | Recruiting | Seville | Spain |
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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