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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
NCT04991831 · InSightec
In plain English
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About this study
This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD.
The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:
* Adverse Events (AEs) (does not apply to Baseline Visit)
* Medication usage
* Clinical Rating Scale for Tremor (CRST) ON medication
* Unified Parkinson's Disease Rating Scale Part III ON medication
* EQ-5D-5L
* WPAI-GH
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.
Study design
Enrollment target: 50 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-04-28
Estimated completion: 2027-12
Last updated: 2026-03-20
Interventions
Device: Unilateral thalamotomy
Primary outcomes
- • Long-term adverse events. (Five years.)
Sponsor
InSightec · industry
Contacts & investigators
ContactMatt Hibert · contact · clinicalresearchquestions@insightec.com · 214-630-2000
All locations (8)
Miami Neuroscience Institute Baptist HealthRecruiting
Miami, Florida, United States
Rush UniversityRecruiting
Chicago, Illinois, United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, United States
Weill Cornell MedicineRecruiting
New York, New York, United States
Novant Health Brain & Spine SurgeryRecruiting
Huntsville, North Carolina, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Miami Valley HospitalRecruiting
Fairborn, Ohio, United States
University of DundeeRecruiting
Dundee, Scotland, United Kingdom