Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Florida
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Biphasic deep brain stimulation
- Conventional deep brain stimulation
- Theta burst deep brain stimulation
- Multi frequency deep brain stimulation
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Florida
Lead sponsor
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov