A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD

Study Overview
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Brief Summary
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The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features

Detailed Description
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The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.

Official Title
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A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease

Conditions
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Parkinson Disease, Neurologic Manifestations

Intervention / Treatment
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* Device: Exablate Bilateral Subthalamotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female age 30 years or older Able and willing to give consent and able to attend all study visits A confirmed diagnosis of Parkinsons Disease Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms Able to localize subthalamic nucleus on MRI for treatment Able to communicate sensations during the ExAblate MRgFUS procedure Exclusion Criteria: Hoehn and Yahr stage in the ON medication state of 2.5 or greater Presence of severe dyskinesia as noted by MDS-UPDRS scores Presence of other central neurodegenerative disease Parkinsonian symptoms are a side effect from neuroleptic medications Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse History of a bleeding disorder or receiving anticoagulant Subjects with advanced kidney disease or on dialysis Subjects with known intolerance or allergies to the MRI contrast agents. Presence of unknown or MRI unsafe devices anywhere in the body. History of multiple strokes, or a stroke within past 6 months Subjects with a history of seizures within the past year Subjects with malignant brain tumors Women who are pregnant or nursing

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExAblate 4000 System<br>Exablate bilateral treatment for Parkinson's Disease Motor Features | Device: Exablate Bilateral Subthalamotomy<br>* Exablate bilateral treatment for Parkinson's Disease Motor Features<br>* Other names: Subthalamotomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse Events | To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features. | Treatment through 6 month | 
| Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status | Effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy by analyzing mean change (reduction from baseline to 6 months) in the motor MDS-UPDRS score in the treated group as compared with baseline in the off-medication condition | Treatment through 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status | - Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable) | Treatment through 6 month | 
| MDS-UPDRS | - Mean change (reduction) in specific PD motor features (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores) | Treatment through 12 month | 
| MDS-UPDRS (Part I, II and IV) | MDS UPDRS I, II and IV | Treatment through 6 month | 
| Quality of life assessment | Improved Quality of life assessment with the PDQ39 | Treatment through 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRgFUS, ExAblate, Parkinsons Disease, Sub-Thalamotomy