Automated Parkinson's Disease (PD) Motor Symptom Assessment for Deep Brain Stimulation (DBS) Programming
NCT ID: NCT01429220
Last Updated: 2014-09-15
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
9 participants
OBSERVATIONAL
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Average tremor and/or bradykinesia Unified Disease Rating Scale (UPDRS) score greater than 2 off meds
* L-dopa responsive with clearly defined "on" periods, UPDRS motor III average tremor and bradykinesia improves by 25%
* Stable on medical therapy for at least one month prior to study enrollment
* Clinical approval to undergo unilateral DBS surgery targeting the STN or GPi
* Available to participate for six months following DBS surgery
Exclusion Criteria
* previous Parkinson's Disease surgery
* medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility)
* contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI)
* neuropsychological dysfunction (e.g. dementia) that would contraindicate surgery
* intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)
21 Years
90 Years
ALL
No
Sponsors
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Great Lakes NeuroTechnologies Inc.
INDUSTRY
Responsible Party
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Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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