Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
University of Florida
60 participants
May 6, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System
- Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist
- Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months
Exclusion Criteria3
- History of previous neurosurgical intervention aside from DBS
- Diagnosis of dementia (whether primary or related to Parkinson's disease)
- A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation
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Interventions
Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially
Conventional deep brain stimulation programming that is currently FDA approved
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
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)
View Full Details on ClinicalTrials.gov
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NCT07410598