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Deep Brain Stimulation (DBS) Retrospective Outcomes Study

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ClinicalTrials.gov Identifier: NCT03664609
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment
Parkinson Disease Essential Tremor Dystonia Device: Deep Brain Stimulation

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Deep Brain Stimulation (DBS) Retrospective Outcomes Study
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : June 29, 2028
Estimated Study Completion Date : June 29, 2028


Group/Cohort Intervention/treatment
Parkinson's Disease
Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System
Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.

Essential Tremor
Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System
Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.

Dystonia
Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System
Device: Deep Brain Stimulation
Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.




Primary Outcome Measures :
  1. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects' chart data will be drawn from the Investigator's standard patient pool treated at his/her practice.
Criteria

Inclusion Criteria:

  • Must be previously treated with or eligible for implantation with a deep brain stimulation system

Exclusion Criteria:

  • No Exclusion Criteria

Information from the National Library of Medicine

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): NCT03664609


Contacts
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Contact: Diane Keesey 661-949-4175 diane.keesey@bsci.com
Contact: Roshini Jain 469-766-9888 roshini.jain@bsci.com

Locations
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United States, California
Boston Scientific Clinical Research Information Toll Free Number Recruiting
Valencia, California, United States, 91355
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Study Director: Roshini Jain Boston Scientific Neuromodulation Corporation

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03664609     History of Changes
Other Study ID Numbers: A4170
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms