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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
6
Exablate bilateral treatment for Parkinson's Disease Motor Features
Hospital Universitario HM Puerta Del Sur. CINAC
Móstoles, Madrid, Spain
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.
Time frame: 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
Time frame: Treatment through 6 month
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)
Time frame: 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)
Time frame: Treatment through 12 month
MDS-UPDRS (Part I, II and IV)
MDS UPDRS I, II and IV
Time frame: Treatment through 6 month
Quality of life assessment
Improved Quality of life assessment with the PDQ39
Time frame: Treatment through 6 month
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