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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Tremor Associated With Tremor Dominant Parkinson's Disease

Intervention / Treatment
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* Device: Unilateral thalamotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, age 30 years and older Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease<br>This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol. | Device: Unilateral thalamotomy<br>* Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term adverse events. | This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system. | Five years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tremor/motor intensity and impact on disability | Long term tremor motor scores and the impact of tremor on disability will be monitored using components of the Clinical Rating Scale for Tremor (CRST) | Five years. |