NCT07410598

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 the three parallel study arms. At the baseline visit, each participant will be programmed with two stimulation settings: one replicating their chronic best clinical setting, and a second incorporating the assigned patterned stimulation. For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing. 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. 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. Participants will be blinded to the identity of the two settings and will be able to switch between them using their patient programmer. The study will follow a randomized, blinded, two-period crossover design over a total duration of four weeks. During the first two weeks, participants will use one of the two programmed settings. At the end of this period, a telemedicine visit will be conducted to collect quality of life (QoL) questionnaires, related surveys, and a video-based modified MDS-UPDRS assessment. Participants will then switch to the alternate setting for the remaining two weeks. At the conclusion of the study, participants will return for an in-person research visit to complete the same assessments for the second setting. This design allows for within-subject comparison of conventional DBS and patterned DBS in a real-world, home-based environment, and will generate critical data to inform the design of a future large-scale trial.

Conditions

• Parkinson Disease
• Deep Brain Stimulation

Interventions

Type	Name	Description
DEVICE	Biphasic deep brain stimulation	Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially
DEVICE	Conventional deep brain stimulation	Conventional deep brain stimulation programming that is currently FDA approved
DEVICE	Theta 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
DEVICE	Multi 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

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study