A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications

Study Overview
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Brief Summary
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This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.

Detailed Description
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This is a post-approval registry which is required by of the approval under PMA P150038/S014 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral pallidotomy in the treatment of idiopathic Parkinson's Disease with medication-refractory moderate to severe motor complications. Subjects participating in this registry will have received a unilateral pallidotomy using the commercially available Exablate Neuro. The following assessments will be collected at Baseline, 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 MDS-UPDRS Unified Dyskinesia Rating Scale EQ-5D-5L WPAI-GH Clinician and Patient Global Impression of Change Patient Satisfaction Questionnaire

Official Title
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A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications

Conditions
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Movement Disorders, Neurology, Parkinsons Disease

Intervention / Treatment
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* Device: Exablate Pallidotomy, Unilateral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, age 30 years and older. Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry 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 Registry.

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 Pallidotomy for Parkinson's Disease with Motor Complications<br>The population enrolled in this registry will be comprised of male and female patients that plan to be treated using the Exablate Neuro system for advanced, idiopathic Parkinson's disease with medication-refractory moderate to severe motor complications. No intervention is performed under this registry protocol. | Device: Exablate Pallidotomy, Unilateral<br>* Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Analysis | Primary Effectiveness will be evaluated through a Responder analysis. Responder is defined as the patient reaching a minimally clinically significant difference on: 1) UDysRS Objective Assessment ON Meds, without clinically significant worsening of MDS-UPDRS Part III OFF Meds aggregated extremity score for treated side Or 2) MDS-UPDRS Part III OFF Meds Motor Exam on the treated side, without clinically significant worsening of UDysRS Objective Assessment ON meds | 5 years |