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Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation (CLOVER)

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ClinicalTrials.gov Identifier: NCT03037398
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Vercise Deep Brain Stimulation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Novel Arm
Programming completed by a novel method
Device: Vercise Deep Brain Stimulation System
Standard of Care Arm
Programming completed as Standard of care
Device: Vercise Deep Brain Stimulation System



Primary Outcome Measures :
  1. Difference in time to program between the two arms at Programming Visit [ Time Frame: at least six months post implant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Implanted bilaterally in STN with a Vercise™ DBS system for Parkinson's disease for at least six months and programming optimized according to standard of care with no changes to electrode configuration of primary settings for at least four weeks.
  • Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
  • Be at least 18 years of age.

Exclusion Criteria:

  • Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
  • Device must be implanted on label.

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): NCT03037398


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 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: NCT03037398     History of Changes
Other Study ID Numbers: A4063
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases