NCT03811405

Physiology, Imaging and Modeling of Essential Tremor

Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This project aims to investigate novel ways to deliver brain stimulation to Essential Tremor (ET) patients by introducing software changes to their existing devices. The study team aims to investigate safety and efficacy of these new stimulation parameters in patients with ET.

Detailed description

Deep brain stimulation (DBS) is a neuromodulatory therapy that is effective in a subset of well selected essential tremor (ET) patients. However, as many as 1/5 of patients may initially improve, but then steadily worsen following the operation. The investigators developed a technique to study a variety of alternative stimulation methods without the use of an invasive repeat surgical intervention. The electrophysiological effects of non-conventional DBS differ from traditional DBS, however the physiological differences in the setting of human tremor remain largely unknown. This study plans to explore gaps in knowledge of neuromodulation and will collect and contribute essential information to the underlying mechanism of action of DBS. The hypothesis of this project centers around active biphasic stimulation providing a wider therapeutic window and a lower adverse event profile as compared to conventional DBS.

Conditions

• Essential Tremor
• Parkinson Disease
• Dystonia

Interventions

Type	Name	Description
DEVICE	Active biphasic pulse stimulation---Home Settings	During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.
DEVICE	Active biphasic pulse stimulation---VIN Biphasic	During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.
DEVICE	Active biphasic pulse stimulation---Stimulator Off	During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2019-01-22
• Last updated: 2025-06-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study