Bilateral Treatment of Medication Refractory Essential Tremor
NCT04112381 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2025-05-01
Summary
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.
Conditions
Interventions
- DEVICE
-
Exablate Model 4000 Type 1.0/1.1
Exablate thalamotomy of non tremor dominant side of the brain
Sponsors & Collaborators
-
InSightec
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-30
- Primary Completion
- 2026-03-31
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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