Study to Characterize Acute and Chronic Directional Aspects of Deep Brain Stimulation
NCT ID: NCT02835274
Last Updated: 2020-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2016-07-19
2018-12-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Ring mode followed by Unrestricted mode
omni-directional stimulation followed by unrestricted Mode stimulation
BSC Deep Brain Stimulation System with Directional Lead
Unrestricted mode followed by ring mode
Unrestricted Mode stimulation followed by omni-directional stimulation
BSC Deep Brain Stimulation System with Directional Lead
Interventions
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BSC Deep Brain Stimulation System with Directional Lead
Eligibility Criteria
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Inclusion Criteria
* UPDRS III score of \>25 in the meds OFF condition
* Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score
Exclusion Criteria
* Any current drug or alcohol abuse as determined by the investigator
* Any history of recurrent or unprovoked seizures
* Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Roshini Jain
Role: STUDY_DIRECTOR
Boston Scientific Neuromodulation Corporation
Locations
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CHU Grenoble - Hopital Michallon
Grenoble, , France
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Academisch Medisch Centrum
Amsterdam, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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A4150
Identifier Type: -
Identifier Source: org_study_id