Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
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|ClinicalTrials.gov Identifier: NCT03465761|
Recruitment Status : Not yet recruiting
First Posted : March 14, 2018
Last Update Posted : October 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: ExAblate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: ExAblate 4000 System
ExAblate treatment of Bilateral Essential Tremor
Bilateral side treatment of Essential Tremor
- Clinical Rating Scale for Tremor (CRST) [ Time Frame: Baseline through Month 12 after First and Second Treatment ]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.
- Incidence of Device and Procedure related Adverse Events [ Time Frame: Treatment through Month 12 after Second Treatment ]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.