The objective of this prospective, multi-site, single-arm, open-label study is to capture the safety and efficacy (outcome) of bilateral staged Exablate treatment in subjects with bilateral medication-refractory essential tremor (ET). The staged second procedure will be performed at least 9 months after the first side. The benefit of real-time feedback will allow the physician to maximize benefit without jeopardizing safety. This study is designed as a prospective, open-label, single arm, multi-site study design.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Bilateral side treatment of Essential Tremor
HM CINAC
Móstoles, Madrid, Spain
Imperial College
London, United Kingdom
Clinical Rating Scale for Tremor (CRST)
The CRST is a standard tremor rating scale which measures subjects' tremor (Part A), motor Function (Part B), and Activities of Daily Living (Part C). Scores range from 0-4 with 0 being no tremor.
Time frame: Baseline through Month 12 after First and Second Treatment
Incidence of Device and Procedure related Adverse Events
All AEs will be reported and categorized by investigators in relation to the device or procedure, disease or unrelated to the device or procedures and categorized by first or second Exablate thalamotomy.
Time frame: Treatment through Month 12 after Second Treatment
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