Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Joshua Wong, MD
joshua.wong@neurology.ufl.edu
352-294-5400
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 60
Treatments
Experimental: Biphasic DBS (bDBS)
For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing.
Experimental: Nocturnal Theta Burst Stimulation (tDBS)
In the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule
Experimental: Region-Specific Frequency Alternation (fDBS)
For those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters.
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation
Leads: University of Florida