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Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting

RecruitingNA

Sponsor: University of Florida

Conditions: Parkinson Disease, Deep Brain Stimulation

Interventions: Biphasic deep brain stimulation, Conventional deep brain stimulation, Theta burst deep brain stimulation, Multi frequency deep brain stimulation

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Gainesville, Florida, United States