Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2019-01-13
2025-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Novel Deep Brain Stimulation (nDBS) program
This arm will include patients receiving stimulation with a novel Deep Brain Stimulation (nDBS) for Parkinson's Disease (PD).
Novel Programming (nDBS)
The commercial CP installed with the investigational DBS programming software will be used to set up Novel Programming (nDBS) therapy on the IPG.
Conventional Deep Brain Stimulation (cDBS) program
This arm will include patients receiving stimulation with a conventional Deep Brain Stimulation (cDBS) for Parkinson's Disease (PD).
Conventional Programming (cDBS)
The commercial CP installed with commercial software will be used to set up standard cDBS therapy on the IPG.
Interventions
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Novel Programming (nDBS)
The commercial CP installed with the investigational DBS programming software will be used to set up Novel Programming (nDBS) therapy on the IPG.
Conventional Programming (cDBS)
The commercial CP installed with commercial software will be used to set up standard cDBS therapy on the IPG.
Eligibility Criteria
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Inclusion Criteria
2. Tolerates \> 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures.
3. Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed.
Exclusion Criteria
2. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Natalie Bloom Lyons
Role: STUDY_DIRECTOR
Boston Scientific Neuromodulation Corporation
Locations
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University Berlin, Charite Virchow
Berlin, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Countries
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Other Identifiers
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A4058
Identifier Type: -
Identifier Source: org_study_id
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