Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02071134|
Recruitment Status : Recruiting
First Posted : February 25, 2014
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment|
|Parkinson's Disease||Device: Deep Brain Stimulation (DBS)|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry|
|Actual Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2024|
Subjects with Parkinson's disease who will receive Vercise DBS for deep brain stimulation.
Device: Deep Brain Stimulation (DBS)
Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.
- Improvement in patient's quality of life (QoL) during the study as compared with baseline [ Time Frame: up to 3 years ]Change in quality of life assessments during the study as compared with baseline
- Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline [ Time Frame: up to 3 years ]Change in patient's motor symptoms as determined by UPDRS during the study as compared with baseline
- Change in medication usage during the study as compared with baseline [ Time Frame: up to 3 years ]
- Impression of change scores during the study as compared with baseline [ Time Frame: 3 years ]Impression of change scores during the study as compared with baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071134
|Contact: Diane Bowers||Diane.firstname.lastname@example.org|
|Contact: Roshini Jain||469-766-9888||Roshini.Jain@bsci.com|
|United States, California|
|Boston Scientific Clinical Research Toll-Free Number||Recruiting|
|Valencia, California, United States, 91355|
|Contact 855-213-9890 BSNClinicalTrials@bsci.com|
|Study Director:||Roshini Jain||Boston Scientific Neuromodulation Corporation|