The objective of this study is to test the efficacy and safety of unilateral subthalamotomy performed using the ExAblate System for the treatment of Parkinson's disease (PD) motor features.
A Prospective, Randomized, Sham Controlled Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the treatment of Parkinson's disease motor features. The objective of this prospective, randomized, double-blind (to subjects, examining neurologists and external video-based examination by Movement Disorders neurologist), two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to confirm the efficacy of ExAblate Model 4000 Type 1 System for the treatment of Parkinson's disease (PD) motor features and to further demonstrate safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
Sham ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
Hospital Universitario HM Puerta Del Sur. CINAC
Móstoles, Madrid, Spain
Efficacy - MDS-UPDRS
between-group differences in the mean change (from baseline to 4 months) in the motor MDS-UPDRS score for the side contralateral to subthalamotomy (in the treated group) as compared with mean change in the MDS-UPDRS score for the side contralateral to the alleged subthalamotomy (in the sham-procedure group) in the off-medication condition
Time frame: Baseline to 4 months post treatment
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: Baseline to 4 Months post treatment
MDS-UPDRS III ON-medication
MDS-UPDRS III score in the contralateral body side ON-medication condition as measured by the BLINDED assessor
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS III OFF-medication
MDS-UPDRS III score in the contralateral body side OFF-medication condition as measured by the UNBLINDED assessor
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS III- Contralateral ON-medication
MDS-UPDRS III score in the contralateral body side ON-medication condition as measured by the UNBLINDED assessor
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS III
Specific PD motor features sub-scores (rigidity, bradykinesia, tremor) of MDS- UPDRS III in the contralateral body side by visit for the following: OFF and ON-medication condition as measured by the BLINDED assessor
Time frame: Baseline to Month 4 post treatment
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MDS-UPDRS II
Total score of MDS-UPDRS II
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS III Blinded assessor
Total score of MDS-UPDRS III as measured by the BLINDED assessor OFF- and ON-medication
Time frame: Baseline to Month 4 post treatment
MDS-UPDRS IV
Total score of MDS-UPDRS IV and separated by each type of motor complication
Time frame: Baseline to Month 4 post treatment
PDG39
Quality of life assessment with the PDQ39.
Time frame: Baseline to Month 12 post treatment
GIC
Patient global impression of change from Baseline to Month 4 FU.
Time frame: Baseline to Month 4 post treatment
Levodopa
Levodopa equivalent medication change usage (mg).
Time frame: Baseline to Month 12 post treatment
MDS-UPDRS
Durability of the reduction in the contralateral motor MDS-UPDRS at 12 months in the treated group (measured only by the UNBLINDED assessor)
Time frame: Baseline to Month 12 post treatment
MDS-UPDRS
Change in the total MDS-UPDRS III according to disease severity at baseline (as defined by the MDS-UPDRS III score).
Time frame: Baseline to Month 12 post treatment