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出境医 / 临床实验 / Physiology, Imaging and Modeling of Essential Tremor
Physiology, Imaging and Modeling of Essential Tremor
Study Description
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.
Study Design
| 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 |
| Actual Study Start Date : | April 1, 2021 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | January 2022 |
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures :
- 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 Outcome Measures :
- 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.
- 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.
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| 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
| United States, Florida | |
| UF Health at the University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| McKnight Brain Institute--Fixel Center for Neurological Diseases | Not yet recruiting |
| Gainesville, Florida, United States, 32611 | |
Sponsors and Collaborators
University of Florida
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
| Principal Investigator: | Leonardo B Almeida, MD | Univeristy of Florida |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 17, 2019 | ||||||||
| First Posted Date ICMJE | January 22, 2019 | ||||||||
| Last Update Posted Date | April 8, 2021 | ||||||||
| Actual Study Start Date ICMJE | April 1, 2021 | ||||||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Physiology, Imaging and Modeling of Essential Tremor | ||||||||
| Official Title ICMJE | Physiology, Imaging and Modeling of Deep Brain Stimulation for Essential Tremor | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | 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
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | 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.
Interventions:
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
70 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | January 2022 | ||||||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03811405 | ||||||||
| Other Study ID Numbers ICMJE | IRB201802397 -N -A OCR19607 ( Other Identifier: UF OnCore ) 1R25NS108939-01 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | University of Florida | ||||||||
| Study Sponsor ICMJE | University of Florida | ||||||||
| Collaborators ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Florida | ||||||||
| Verification Date | April 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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