Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07410598
NA

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

Sponsor: University of Florida

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-01

Completion Date

2028-03-01

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

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

Locations (1)

University of Florida

Gainesville, Florida, United States