Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

Study Overview
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Brief Summary
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The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).

Detailed Description
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This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1 day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.

Official Title
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A Continued Access Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

Conditions
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Essential Tremor

Intervention / Treatment
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* Device: Transcranial ExAblate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, age 22 years and older Subjects who are able and willing to give informed consent and able to attend all study visits Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder Subject exhibits a significant disability from their ET despite medical treatment Subjects should be on a stable dose of all ET medications for 30 days prior to study entry Subject is able to communicate sensations during the ExAblate Transcranial procedure Exclusion Criteria: Subjects with unstable cardiac status Severe hypertension Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function Significant claustrophobia that cannot be managed with mild medication Current medical condition resulting in abnormal bleeding and/or coagulopathy Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage History of intracranial hemorrhage History of multiple strokes, or a stroke within past 6 months Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment Are participating or have participated in another clinical trial in the last 30 days Subjects unable to communicate with the investigator and staff Subjects with a history of seizures within the past year Subjects with brain tumors

Ages Eligible for Study
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Minimum Age: 22 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial ExAblate<br>Transcranial ExAblate | Device: Transcranial ExAblate<br>* Transcranial ExAblate<br>* Other names: Thalamotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence and severity of adverse events (AEs) |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory Essential Tremor (ET) will be determined using the Clinical Rating Scale for Tremor (CRST) |  | participants will be followed from the date of treatment until study completion, approximately up to 12 months |