Trial Outcomes & Findings for Physiology, Imaging and Modeling of Essential Tremor (NCT NCT03811405)
NCT ID: NCT03811405
Last Updated: 2026-09-03
Results Overview
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.
COMPLETED
NA
12 participants
4 hours
2026-09-03
Participant Flow
Participant milestones
| Measure |
Experimental: Biphasic Settings Then Home Settings
Participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
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Experimental: Home Settings Then Biphasic Settings
Participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Overall Study
STARTED
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6
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6
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Overall Study
COMPLETED
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6
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6
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physiology, Imaging and Modeling of Essential Tremor
Baseline characteristics by cohort
| Measure |
Patients With Essential Tremor
n=12 Participants
Patients with chronically implanted DBS devices for ET who experience progressive worsening of tremor symptoms over time. The DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.
Half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
The other half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Age, Continuous
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71.1 Years
STANDARD_DEVIATION 6.7 • n=136 Participants
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Sex: Female, Male
Female
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7 Participants
n=136 Participants
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Sex: Female, Male
Male
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5 Participants
n=136 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=136 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=136 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=136 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=136 Participants
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Race (NIH/OMB)
White
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12 Participants
n=136 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=136 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=136 Participants
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Region of Enrollment
United States
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12 Participants
n=136 Participants
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PRIMARY outcome
Timeframe: 4 hoursThe 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.
Outcome measures
| Measure |
Patients With Essential Tremor
n=12 Participants
Half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
The other half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Fiber Activation Threshold From Stimulation With ET DBS
Home settings DBS
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1.42 Fiber activation threshold (mA)
Standard Deviation 0.68
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Fiber Activation Threshold From Stimulation With ET DBS
Biphasic DBS
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2.12 Fiber activation threshold (mA)
Standard Deviation 0.95
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PRIMARY outcome
Timeframe: 4 hoursPopulation: 2 videos were corrupted and could not be viewed for blinded clinical rating. This prevented pre/post evaluation for 2 subjects.
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
Outcome measures
| Measure |
Patients With Essential Tremor
n=10 Participants
Half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
The other half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Home Settings DBS Versus Active Biphasic Pulse DBS Settings
Home settings DBS
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-14.5 Score change on the scale
Standard Deviation 11.2
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Home Settings DBS Versus Active Biphasic Pulse DBS Settings
Biphasic DBS
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-16.4 Score change on the scale
Standard Deviation 7.9
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SECONDARY outcome
Timeframe: 4 hourEssential 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.
Outcome measures
| Measure |
Patients With Essential Tremor
n=12 Participants
Half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
The other half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Tremor Motor Physiology
Home settings DBS resting tremor
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0.25 Tremor severity score
Standard Deviation 0.28
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Tremor Motor Physiology
Home settings DBS postural tremor
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0.81 Tremor severity score
Standard Deviation 0.82
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Tremor Motor Physiology
Home settings DBS kinetic tremor
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1.6 Tremor severity score
Standard Deviation 0.52
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Tremor Motor Physiology
Biphasic DBS rest tremor
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0.23 Tremor severity score
Standard Deviation 0.25
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Tremor Motor Physiology
Biphasic DBS postural tremor
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0.81 Tremor severity score
Standard Deviation 0.71
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Tremor Motor Physiology
Biphasic DBS kinetic tremor
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1.43 Tremor severity score
Standard Deviation .58
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SECONDARY outcome
Timeframe: 4 hoursPopulation: There was corruption of the gait data that prevented accurate analysis of the entire cohort
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.
Outcome measures
| Measure |
Patients With Essential Tremor
n=6 Participants
Half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
The other half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Gait Impairment - Step Length
Home settings DBS
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47.88 Step length (cm)
Standard Deviation 5.12
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Gait Impairment - Step Length
Biphasic DBS
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48.49 Step length (cm)
Standard Deviation 4.68
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SECONDARY outcome
Timeframe: 4 hoursPopulation: There was corruption of the gait data that prevented accurate analysis of the entire cohort
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.
Outcome measures
| Measure |
Patients With Essential Tremor
n=6 Participants
Half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
The other half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Gait Impairment - Stride Length
Home settings DBS
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94.97 Stride length (cm)
Standard Deviation 9.05
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Gait Impairment - Stride Length
Biphasic DBS
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97.19 Stride length (cm)
Standard Deviation 7.61
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SECONDARY outcome
Timeframe: 4 hoursPopulation: There was corruption of the gait data that prevented accurate analysis of the entire cohort
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.
Outcome measures
| Measure |
Patients With Essential Tremor
n=6 Participants
Half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
The other half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Gait Impairment - Step Time
Home settings DBS
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0.677 Step time (sec)
Standard Deviation 0.07
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Gait Impairment - Step Time
Biphasic DBS
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0.644 Step time (sec)
Standard Deviation 0.07
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SECONDARY outcome
Timeframe: 4 hoursPopulation: There was corruption of the gait data that prevented accurate analysis of the entire cohort
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.
Outcome measures
| Measure |
Patients With Essential Tremor
n=6 Participants
Half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of active VIN Biphasic stimulation. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of stimulation using the participants' home settings.
The other half of the participants first underwent a 30-minute washout period with DBS turned OFF. This was followed by 4 hours of stimulation using the participants' home settings. Next, a second 30-minute DBS OFF washout was conducted, followed by 4 hours of active VIN Biphasic stimulation.
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Gait Impairment - Gait Cycle Time
Home settings DBS
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1.34 Gait cycle time (sec)
Standard Deviation 0.16
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Gait Impairment - Gait Cycle Time
Biphasic DBS
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1.32 Gait cycle time (sec)
Standard Deviation 0.15
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Adverse Events
Biphasic First Group
Home Settings First Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place