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Physiology, Imaging and Modeling of Essential Tremor

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ClinicalTrials.gov Identifier: NCT03811405
Recruitment Status : Not yet recruiting
First Posted : January 22, 2019
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Essential Tremor Parkinson Disease Dystonia Device: Active biphasic pulse stimulation---Home Settings Device: Active biphasic pulse stimulation---VIN Biphasic Device: Active biphasic pulse stimulation---Stimulator Off Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with chronically implanted DBS devices for ET who experience progressive worsening of tremor symptoms over time.
Masking: None (Open Label)
Masking Description: Each of the 3 interventions will be videotaped for blinded motor score assessment by an independent rater.
Primary Purpose: Treatment
Official Title: Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: Patients with Essential Tremor
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.
Device: Active biphasic pulse stimulation---Home Settings
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.

Device: Active biphasic pulse stimulation---VIN Biphasic
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.

Device: Active biphasic pulse stimulation---Stimulator Off
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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. The Fahn-Tolosa-Marin Tremor Rating Scale [ Time Frame: up to 15 minutes ]
    Essential tremor severity will be assessed by the clinically validated Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS). It is a 0 to 4 scale (0 = no tremor; 4 = severe amplitude of tremor) of 9 different parts of the body. The FTMTRS will be assessed for the various DBS settings.

  2. Tremor motor physiology [ Time Frame: up to 15 minutes ]
    Essential tremor motor physiology will be recorded by the Kinesia ONE accelerometer system. THe Kinesia ONE system is a wireless wearable motion sensor unit and portable transducer that translates the degree of movement into a standardized scale. Tremor physiology will be assessed for the various DBS settings.

  3. Gait impairment [ Time Frame: up to 15 minutes ]
    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, cycle time, step length, stride length, etc measured. Gait parameters will be assessed on the various DBS settings.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811405


Contacts
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Contact: Leonardo B Almeida, MD (352) 294-5400 Leonardo.BritodeAlmeida@neurology.ufl.edu
Contact: Joshua K Wong, MD (352) 294-5400 joshua.wong@neurology.ufl.edu

Locations
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United States, Florida
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
McKnight Brain Institute--Fixel Center for Neurological Diseases
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Leonardo B Almeida, MD Univeristy of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03811405    
Other Study ID Numbers: IRB201802397 -N -A
OCR19607 ( Other Identifier: UF OnCore )
1R25NS108939-01 ( U.S. NIH Grant/Contract )
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Florida:
Deep Brain Stimulation (DBS)
ventralis intermedius nucleus (VIN)
implantable pulse generator (IPG)
Diffusion Tensor Imaging (DTI)
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations