Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
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.
Description
This pilot study will investigate the safety, tolerability, and feasibility of three distinct patterned Deep Brain Stimulation (pDBS) paradigms delivered in a home setting using the Boston Scientific Chronos Research Engine. The three stimulation patterns under evaluation are: 1. Biphasic DBS (bDBS) 2. Nocturnal Theta Burst Stimulation (tDBS) 3. Region-Specific Frequency Alternation (fDBS). Sixty patients with Parkinson's Disease (PD), each with stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS for at least six months, will be enrolled and assigned to one of t…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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
Interventions
- DeviceBiphasic deep brain stimulation
Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially
- DeviceConventional deep brain stimulation
Conventional deep brain stimulation programming that is currently FDA approved
- DeviceTheta 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
- DeviceMulti 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
Location
- University of FloridaGainesville, Florida