Physiology, Imaging and Modeling of Essential Tremor

Parkinson Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dystonia
• Essential Tremor
• Parkinson Disease
• Tremor

• NCT number: NCT03811405
• Study type: Interventional
• Source: University of Florida
• Contact: Leonardo B Almeida, MD
• Phone: (352) 294-5400
• Email: Leonardo.BritodeAlmeida@neurology.ufl.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Completion date: June 30, 2024