Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system

Detailed Description
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This clinical investigation is a feasibility study designed to evaluate the safety and feasibility of the ExAblate Neuro system to perform AF echo imaging in patients diagnosed with idiopathic Essential Tremor. during the standard care procedure for ET, patients will be injected with Definity microbubbles which will enable the ExAblate Neuro system to perform the AF imaging.

Official Title
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Assessment of Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Idiopathic Essential Tremor With Medication Refractory Tremor

Conditions
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Tremor, Essential, Neurologic Manifestations, Tremor

Intervention / Treatment
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* Device: ExAblate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female age 22 years or older Able and willing to give consent and able to attend all study visits A confirmed diagnosis of Essential Tremor resistant to medication therapy Able to fit into MRI unit Able to tolerate the procedure with or without some form of sedation Able to communicate sensations during the ExAblate MRgFUS procedure Able to activate Stop Sonication button during the ExAblate MRgFUS procedure Exclusion Criteria: Presence of unknown or MRI unsafe devices anywhere in the body. Patients with known intolerance or allergies to the MRI contrast agents Women who are pregnant Patients with advanced kidney disease or on dialysis Significant cardiac disease or unstable hemodynamic status Patients exhibiting any behavior(s) consistent with ethanol or substance abuse History of a bleeding disorder Patients receiving anticoagulant or drugs known to increase risk of hemorrhage Patients with cerebrovascular disease Patients with brain tumors Individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours) Patients who are currently participating in another clinical investigation Patients unable to communicate with the investigator and staff Patients who have cardiac shunts Patients with relative contraindications to Definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's Patients with chronic pulmonary disorders Patients with a history of drug allergies, uncontrolled asthma or hay fever Patients who have had deep brain stimulation or a prior neuroablative procedure Women who are pregnant or nursing Patients who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to enrollment in the study.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExAblate 4000 System<br>ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor | Device: ExAblate<br>* Auto Focusing (AF) echo imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Device and Procedure related Adverse Events |  | Treatment through 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRgFUS, ExAblate, Essential Tremor, Auto-Focusing Echo Imaging