Essential TremorNCT03811405
Physiology, Imaging and Modeling of Essential Tremor
A study testing Active biphasic pulse stimulation---Home Settings, Active biphasic pulse stimulation---VIN Biphasic and Active biphasic pulse stimulation---Stimulator Off in people with Essential Tremor and Parkinson Disease, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Tremor, Parkinson Disease, Dystonia
- What is being tested?
- Active biphasic pulse stimulation---Home Settings, Active biphasic pulse stimulation---VIN Biphasic and Active biphasic pulse stimulation---Stimulator Off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2021to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No diagnosis of Essential Tremor
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health at the University of Florida
Gainesville, Florida, 32610
McKnight Brain Institute--Fixel Center for Neurological Diseases
Gainesville, Florida, 32611
About this study
Official title: Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor
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.
Read the 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.
- Conditions
- Essential Tremor, Parkinson Disease, Dystonia
- Being tested
- Active biphasic pulse stimulation---Home Settings, Active biphasic pulse stimulation---VIN Biphasic, Active biphasic pulse stimulation---Stimulator Off
- Keywords
- Deep Brain Stimulation (DBS), ventralis intermedius nucleus (VIN), implantable pulse generator (IPG), Diffusion Tensor Imaging (DTI)
- Medical subject headings
- Essential Tremor, Parkinson Disease, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active biphasic pulse stimulation---Home SettingsDevice
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.
Active biphasic pulse stimulation---VIN BiphasicDevice
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.
Active biphasic pulse stimulation---Stimulator OffDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Essential Tremor | Experimental | 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. The following random conditions will be applied: (1) Home Settings; (2) VIN Biphasic; (3) Stimulator Off. A 30-minute washout period will be applied between each of the random conditions. Therefore, each patient will serve as their own control. Receives: Device: Active biphasic pulse stimulation---Home Settings; Device: Active biphasic pulse stimulation---VIN Biphasic; Device: Active biphasic pulse stimulation---Stimulator Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 hours
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Apr 2021
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with chronically implanted DBS devices for ET who experience progressive worsening of tremor symptoms over time.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Medtronic
- Responsible party
- Sponsor
- Investigators
- Joshua K Wong, MD, Principal investigator, Univeristy of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811405
- Sponsor's protocol ID
- IRB201802397 -N -A
- Other IDs
- OCR19607, 5R25NS108939-04, MEDTRONIC INC
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2019
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor
- ClinicalTrials.gov ID
- NCT03811405
- Acronym / sponsor ID
- IRB201802397 -N -A
- Conditions
- Essential Tremor, Parkinson Disease, Dystonia
- Keywords
- Deep Brain Stimulation (DBS), ventralis intermedius nucleus (VIN), implantable pulse generator (IPG), Diffusion Tensor Imaging (DTI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Medtronic
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Posted 3 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with chronically implanted DBS devices for ET who experience progressive worsening of tremor symptoms over time.
| Arm | Type | Receives |
|---|---|---|
| Patients with Essential Tremor | Experimental | Device: Active biphasic pulse stimulation---Home Settings, Device: Active biphasic pulse stimulation---VIN Biphasic, Device: Active biphasic pulse stimulation---Stimulator OffPatients 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. The following random conditions will be applied: (1) Home Settings; (2) VIN Biphasic; (3) Stimulator Off. A 30-minute washout period will be applied between each of the random conditions. Therefore, each patient will serve as their own control. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- No diagnosis of Essential Tremor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active biphasic pulse stimulation---Home SettingsDuring this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation. | Device | Patients with Essential Tremor |
| Active biphasic pulse stimulation---VIN BiphasicDuring this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation. | Device | Patients with Essential Tremor |
| Active biphasic pulse stimulation---Stimulator OffDuring this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation. | Device | Patients with Essential Tremor |
Primary outcome
Fiber Activation Threshold From Stimulation With ET DBS
Time frame: 4 hours
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.
Home Settings DBS Versus Active Biphasic Pulse DBS Settings
Time frame: 4 hours
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
5 secondary outcomes
Tremor Motor Physiology
Time frame: 4 hour
Gait Impairment - Step Length
Time frame: 4 hours
Gait Impairment - Stride Length
Time frame: 4 hours
Gait Impairment - Step Time
Time frame: 4 hours
Gait Impairment - Gait Cycle Time
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Essential Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
Phenotype/Genotype Correlations in Movement Disorders
Movement Disorder
RecruitingPhase 2
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Upper Limb Essential Tremor
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
RecruitingPhase 2
Stereotactic Radiosurgery in the Treatment of Essential Tremor
Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua K Wong, MD principal investigator
Univeristy of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active biphasic pulse stimulation---Home Settings, Active biphasic pulse stimulation---VIN Biphasic and Active biphasic pulse stimulation---Stimulator Off in people with Essential Tremor and Parkinson Disease, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fiber Activation Threshold From Stimulation With ET DBS (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.