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A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease
Sponsor: InSightec
Summary
The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
Key Details
Gender
All
Age Range
30 Years - 99 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2022-04-28
Completion Date
2027-12
Last Updated
2026-03-20
Healthy Volunteers
No
Interventions
Unilateral thalamotomy
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Locations (8)
Miami Neuroscience Institute Baptist Health
Miami, Florida, United States
Rush University
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Weill Cornell Medicine
New York, New York, United States
Novant Health Brain & Spine Surgery
Huntsville, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Miami Valley Hospital
Fairborn, Ohio, United States
University of Dundee
Dundee, Scotland, United Kingdom