Automated Deep Brain Stimulation Programming Using Functional Mapping
NCT ID: NCT02765282
Last Updated: 2019-06-27
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-10-01
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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DBS-Expert Programming First
These patients will be undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) first and then be programmed by a clinician within five days.
Algorithm based programming using Kinesia-based assessment
DBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters.
Traditional Programming First
These patients will be programmed by a clinician first and then undergo algorithm based programming using Kinesia-based assessment (DBS-Expert) within five days.
Algorithm based programming using Kinesia-based assessment
DBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters.
Interventions
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Algorithm based programming using Kinesia-based assessment
DBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of idiopathic Parkinson's disease (PD)
* Implanted deep brain stimulation (DBS) system for tremor and/or bradykinesia
Exclusion Criteria
* Not capable of functioning independently
* Individuals so symptomatic as to compromise safety
35 Years
80 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Ohio State University
OTHER
Wake Forest University
OTHER
Great Lakes NeuroTechnologies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dustin A Heldman, PhD
Role: PRINCIPAL_INVESTIGATOR
Great Lakes NeuroTechnologies Inc.
Locations
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Atrium Health
Charlotte, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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