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
NCT ID: NCT04991831
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-04-28
2027-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease
This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol.
Unilateral thalamotomy
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Interventions
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Unilateral thalamotomy
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
Eligibility Criteria
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Inclusion Criteria
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
30 Years
99 Years
ALL
No
Sponsors
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InSightec
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PD012
Identifier Type: -
Identifier Source: org_study_id
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