The purpose of this study is to assess the recharge feature of the Activa RC System in patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD), Essential Tremor (ET), or dystonia.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
100
Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
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Washington D.C., District of Columbia, United States
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Cincinnati, Ohio, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
Identify the Rate of User-related Battery Depletion Adverse Events Per Subject-month Requiring Intervention by a Health Care Professional (HCP) and/or the HCP's Designee, Within the First 3 Months of the Activa RC System Being Turned ON.
Subject-months of follow-up were defined as the time from device activation to the earlier of a subject's 3-month visit or until the subject exited from the study. Any user-related battery depletion adverse events requiring intervention by a health care professional (HCP) and/or the HCP's designee were collected. The event rate per 100 subject-months of follow-up is defined as the number of user-related battery depletion events divided by the total subject follow-up months through the 3-month visit, all multiplied by 100.
Time frame: 3 months
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Tyler, Texas, United States
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Vienna, Austria
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Montpellier, France
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Cologne, Germany
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Hanover, Germany
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Barcelona, Spain
...and 1 more locations