Physiology, Imaging and Modeling of Essential Tremor

Last updated: June 24, 2025
Sponsor: University of Florida
Overall Status: Completed

Phase

N/A

Condition

Essential Tremor

Dystonia

Treatment

Active biphasic pulse stimulation---Stimulator Off

Active biphasic pulse stimulation---VIN Biphasic

Active biphasic pulse stimulation---Home Settings

Clinical Study ID

NCT03811405
IRB201802397 -N -A
5R25NS108939-03
MEDTRONIC INC
OCR19607
5R25NS108939-04
1R25NS108939-01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Existing unilateral or bilateral VIN DBS for ET, non-demented (MMSE>24), and musthave a documented suboptimal tremor suppression on two successive visits (comparedto the baseline post-operative improvement at 6 months following ET DBS surgery).For bilateral cases, the most affected tremor side will be studied.

Exclusion

Exclusion Criteria:

  • No diagnosis of Essential Tremor

Study Design

Total Participants: 12
Treatment Group(s): 3
Primary Treatment: Active biphasic pulse stimulation---Stimulator Off
Phase:
Study Start date:
April 01, 2021
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • McKnight Brain Institute--Fixel Center for Neurological Diseases

    Gainesville, Florida 32611
    United States

    Site Not Available

  • UF Health at the University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

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