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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
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.
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.
UF Health at the University of Florida
Gainesville, Florida, United States
McKnight Brain Institute--Fixel Center for Neurological Diseases
Gainesville, Florida, United States
Fiber Activation Threshold From Stimulation With ET DBS
The study team will use computer simulation and virtual reconstruction of the brain from pre-operative MRI data to calculate the fiber activation threshold for the duration that each subject is on the home settings versus the biphasic settings. 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. No fiber activation threshold data was collected for the DBS OFF state since the system was not active.
Time frame: 4 hours
Home Settings DBS Versus Active Biphasic Pulse DBS Settings
The investigators will compare the degree of tremor suppression from the home settings versus active biphasic DBS. The degree of tremor will be quantified by the Fahn-Tolosa-Marin Tremor Rating Scale (sum of motor score parts A and B; range 0 - 116). A higher Tremor Rating Scale score is associated with more severe motor symptoms. The clinical metrics represent the change from DBS OFF to the active arm (either home settings or biphasic VIN) after 4 hours of stimulation
Time frame: 4 hours
Tremor Motor Physiology
Essential tremor motor physiology will be recorded by the Kinesia ONE accelerometer system. The Kinesia ONE system utilizes a wireless, wearable motion sensor and portable transducer to translate movement metrics into a tremor severity score ranging from 0 (no symptoms) to 4 (severe symptoms). In this study, the reported tremor severity score represents motor function captured after 4 hours of active DBS - under either the participants' home settings or the VIN biphasic configuration.
Time frame: 4 hour
Gait Impairment - Step Length
Essential tremor's effect on gait will be assessed by the GAITRite system. Patients will walk along a GAITRite floor mat to have the various gait parameters such as step length measured. The GAITRite system translates movement metrics into an objective kinematic score. In this study, the reported kinematic scores represent motor function captured after 4 hours of active DBS - under either the participants' home settings or the VIN biphasic configuration.
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Time frame: 4 hours
Gait Impairment - Stride Length
Essential tremor's effect on gait will be assessed by the GAITRite system. Patients will walk along a GAITRite floor mat to have the various gait parameters such as stride length measured. The GAITRite system translates movement metrics into an objective kinematic score. In this study, the reported kinematic scores represent motor function captured after 4 hours of active DBS - under either the participants' home settings or the VIN biphasic configuration.
Time frame: 4 hours
Gait Impairment - Step Time
Essential tremor's effect on gait will be assessed by the GAITRite system. Patients will walk along a GAITRite floor mat to have the various gait parameters such as step time measured. The GAITRite system translates movement metrics into an objective kinematic score. In this study, the reported kinematic scores represent motor function captured after 4 hours of active DBS - under either the participants' home settings or the VIN biphasic configuration.
Time frame: 4 hours
Gait Impairment - Gait Cycle Time
Essential tremor's effect on gait will be assessed by the GAITRite system. Patients will walk along a GAITRite floor mat to have the various gait parameters such as gait cycle time measured. The GAITRite system translates movement metrics into an objective kinematic score. In this study, the reported kinematic scores represent motor function captured after 4 hours of active DBS - under either the participants' home settings or the VIN biphasic configuration.
Time frame: 4 hours