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(352) 733-0111

Physiology, Imaging and Modeling of Essential Tremor

  • Status
    Accepting Candidates
  • Age
    18 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

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.

Details

Full study title Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor
Protocol number OCR19607
ClinicalTrials.gov ID NCT03811405
Phase N/A

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • No diagnosis of Essential Tremor

Lead researcher

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  4. Step
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