Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Essential Tremor
- Sponsor
- University of Florida
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Volume of tissue activated from stimulation with ET DBS
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Volume of tissue activated from stimulation with ET DBS
Time Frame: up to 24 hours
The study team will use computer simulation and virtual reconstruction of the brain from pre-operative MRI data to calculate the volume of tissue activated (VTA) from the novel stimulation patterns. The investigators will assess the feasibility of the patterns to address the worsening of ET that may occur in 20% or more of the ET population.
Baseline DBS settings versus active biphasic pulse DBS settings
Time Frame: up to 1 hour
The investigators will compare the degree of tremor suppression from the most optimal DBS settings that can be obtained via traditional programming methods versus active biphasic DBS. The degree of tremor will be quantified by multiple clinical metrics including the Fahn-Tolosa-Marin Tremor Rating Scale and Kinesia ONE® accelerometer system.
Secondary Outcomes
- Tremor motor physiology(up to 15 minutes)
- The Fahn-Tolosa-Marin Tremor Rating Scale(up to 15 minutes)
- Gait impairment(up to 15 minutes)