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Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
Sponsor: University of Florida
Summary
The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-03-01
Completion Date
2028-03-01
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
Biphasic deep brain stimulation
Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially
Conventional deep brain stimulation
Conventional deep brain stimulation programming that is currently FDA approved
Theta burst deep brain stimulation
Deep brain stimulation using a conventional waveform but timed such that in the evening hours (based on device clock) the device will adjust stimulation to bursts of conventional stimulation at 6 per second
Multi frequency deep brain stimulation
Deep brain stimulation using conventional waveforms but simultaneously delivering high frequency stimulation on the dorsal contacts of the DBS lead and low frequency stimulation on the ventral contacts of the DBS lead
Locations (1)
University of Florida
Gainesville, Florida, United States