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| ID | Type | Description | Link |
|---|---|---|---|
| A4069 | Other Identifier | Boston Scientific Corporation U.S. Study |
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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.
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.
Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's disease | Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 3 years |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 3 years |
| Change in medication usage during the study as compared with baseline |
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.
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Patients with symptoms of Parkinson's disease that are not adequately controlled with medication
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heleen Scholtes | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com | |
| Alison Lewis | 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 |
|---|---|---|---|---|---|---|
| Neurology and Pain Specialty | Withdrawn | Aliso Viejo | California | 92656 | United States | |
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|
| up to 3 years |
| Impression of change scores during the study as compared with baseline | Impression of change scores during the study as compared with baseline | 3 years |
| Cedars Sinai Medical Center |
| Recruiting |
| Los Angeles |
| California |
| 90048 |
| United States |
|
| University of Colorado | Recruiting | Aurora | Colorado | 80220 | United States |
|
| St. Mary's Hospital and Medical Center | Recruiting | Grand Junction | Colorado | 81501 | United States |
|
| University of Florida Shands Hospital | Recruiting | Gainesville | Florida | 32610 | United States |
|
| Mayo Clinic, Jacksonville | Withdrawn | Jacksonville | Florida | 32224 | United States |
| University of Miami Hospital | Recruiting | Miami | Florida | 33136 | United States |
|
| Tallahassee Neurological Clinic, PA | Withdrawn | Tallahassee | Florida | 32308 | United States |
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
|
| St. Luke Regional Medical Center | Recruiting | Boise | Idaho | 83702 | United States |
|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
|
| Methodist Hospital of Indianapolis | Completed | Indianapolis | Indiana | 46202 | United States |
| Massachusetts General Hospital | Withdrawn | Boston | Massachusetts | 02114 | United States |
| St. Louis University Hospital | Withdrawn | St Louis | Missouri | 63110 | United States |
| Albany Medical College | Completed | Albany | New York | 12208 | United States |
| Northwell Health Neuroscience Institute | Recruiting | Great Neck | New York | 11021 | United States |
|
| University at Buffalo | Recruiting | Williamsville | New York | 14221 | United States |
|
| Wake Forest University School of Medicine | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Cleveland Clinic Foundation | Terminated | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
|
| Vanderbilt University | Withdrawn | Nashville | Tennessee | 37232 | United States |
| Houston Methodist Research Institute | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Texas Health Medical Arts and Research Center | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Texas Institute for Neurological Disorders | Recruiting | Sherman | Texas | 75092 | United States |
|
| University of Virginia Medical Center | Withdrawn | Charlottesville | Virginia | 22903 | United States |
| Evergreen Health | Recruiting | Kirkland | Washington | 98034 | United States |
|
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98195 | United States |
|
| Inland Northwest Research | Recruiting | Spokane | Washington | 99202 | United States |
|
| Fundacion Ineco-Research Facility | Recruiting | Buenos Aires | Argentina |
|
| A.o. LKH Univ.-Kliniken Innsbruck | Recruiting | Innsbruck | Austria |
|
| AZ Sint-Lucas | Active, not recruiting | Ghent | Belgium |
| UZ Gasthuisberg | Active, not recruiting | Leuven | Belgium |
| AZ Delta | Active, not recruiting | Roeselare | Belgium |
| Queen Elizabeth II Health Sciences Center | Active, not recruiting | Halifax | Canada |
| Hopital de Enfant-Jesus | Active, not recruiting | Québec | Canada |
| CHU Henri Mondor | Active, not recruiting | Créteil | France |
| Hopital Neurologique Pierre Wertheimer | Completed | Lyon | France |
| CHU La Timone Hospital | Active, not recruiting | Marseille | France |
| Fondation Ophtalmologique Adolphe de Rothschild | Terminated | Paris | France |
| CHRU Hopital Pontchaillou | Withdrawn | Rennes | France |
| University Berlin, Charite Virchow Standort, Wedding | Recruiting | Berlin | Germany |
|
| Uniklinik Köln | Completed | Cologne | Germany |
| Universitätsklinikum Düsseldorf | Recruiting | Düsseldorf | Germany |
|
| Universitätsklinikum Freiburg | Active, not recruiting | Freiburg im Breisgau | Germany |
| Universitätsklinik Eppendorf | Recruiting | Hamburg | Germany |
|
| St. Barbara-Klinik Hamm-Heessen | Withdrawn | Hamm | Germany |
| Universitätsklinikum Campus Kiel | Recruiting | Kiel | Germany |
|
| Johannes Gutenberg Universitaet Mainz | Withdrawn | Mainz | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH | Recruiting | Marburg | Germany |
|
| Evangelisches Krankenhaus Oldenburg | Recruiting | Oldenburg | Germany |
|
| Universitätsklinikum Würzburg | Recruiting | Würzburg | Germany |
|
| Medical School of University PECS | Active, not recruiting | Pécs | Hungary |
| Hadassah Hebrew University Medical Center | Active, not recruiting | Jerusalem | Israel |
| Tel Aviv Sourasky Medical Center | Completed | Tel Aviv | Israel |
| Sheba Medical Center | Completed | Tel Litwinsky | Israel |
| Villa Margherita | Terminated | Arcugnano | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara | Completed | Ferrara | Italy |
| Ospedale Dell Angelo | Terminated | Mestre | Italy |
| IRCCS Istituto Ortopedico Galeazzi | Terminated | Milan | Italy |
| Fondazione Istituto Neurologico Casimiro Mondino | Completed | Pavia | Italy |
| Policlinico Universitario Agostino Gemelli | Recruiting | Rome | Italy |
|
| Osp. S. Maria Della Misericordia | Terminated | Udine | Italy |
| 10 Military Clinical Hospital Bydgoszcz | Terminated | Bydgoszcz | Poland |
| Podmiot Leczniczy Copernicus Sp. z o.o. | Completed | Gdansk | Poland |
| Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | Terminated | Warsaw | Poland |
| Samsung Medical Center | Active, not recruiting | Seoul | South Korea |
| Seoul ASAN Medical Center | Terminated | Seoul | South Korea |
| Yonsei University Severance Hospital | Completed | Seoul | South Korea |
| Hospital Clinic de Barcelona | Completed | Barcelona | Spain |
| Hospital De Bellvitge | Active, not recruiting | Barcelona | Spain |
| Centro Especial Ramon y Cajal | Completed | Madrid | Spain |
| Hospital Clinico San Carlos | Completed | Madrid | Spain |
| University Hospital Virgen Arrixaca | Withdrawn | Murcia | Spain |
| Hospital General De Asturias | Active, not recruiting | Oviedo | Spain |
| Hospital Universitario La Fe | Recruiting | Valencia | Spain |
|
| Bahcesehir University Hospital Medical Park Goztepe | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Koc University Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
|
| Southmead Hospital Bristol | Completed | Bristol | United Kingdom |
| Queen Elizabeth University Hospital | Active, not recruiting | Glasgow | United Kingdom |
| The Walton Centre | Completed | Liverpool | United Kingdom |
| Charing Cross Hospital | Recruiting | London | United Kingdom |
|
| King's College Hospital London | Completed | London | United Kingdom |
| St. Georges Hospital | Completed | London | United Kingdom |
| Royal Victoria Infirmary | Active, not recruiting | Newcastle | United Kingdom |
| John Radcliffe Hospital | Completed | Oxford | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| 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 |
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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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