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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ExAblate 4000 System | Experimental | Exablate bilateral treatment for Parkinson's Disease Motor Features |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exablate Bilateral Subthalamotomy | Device | Exablate bilateral treatment for Parkinson's Disease Motor Features |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul Martinez, MD | CINAC-Hospital HM Puerta del Sur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario HM Puerta Del Sur. CINAC | Móstoles | Madrid | 28938 | Spain |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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- 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |