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
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.
Study identifier: NCT04991831. Status: RECRUITING.
Eligibility
Criteria: Inclusion Criteria: 1. Men and women, age 30 years and older 2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care. 3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits 4. Subject has signed and received a copy of the approved informed consent form Exclusion Criteria: Subject does not agree to participate or is unlikely to participate for the entirety of the study.
- Minimum age: 30 Years
- Maximum age: 99 Years
Participating locations
- Miami Neuroscience Institute Baptist Health, Miami, Florida
- Rush University, Chicago, Illinois
- Brigham and Women's Hospital, Boston, Massachusetts
- Weill Cornell Medicine, New York, New York
- Novant Health Brain & Spine Surgery, Huntsville, North Carolina
- Cleveland Clinic Foundation, Cleveland, Ohio
- Miami Valley Hospital, Fairborn, Ohio
- University of Dundee, Dundee, Scotland
Study records are sourced from ClinicalTrials.gov. Confirm current eligibility, recruiting status, and locations in the official record.