Parkinson's disease (PD) is a common, progressive, incurable neurodegenerative disease that can result in severe disability and impairment in health-related quality of life. Current medical and surgical therapies are aimed toward maximal symptom relief with minimal associated side effects or morbidity. It is generally accepted that a well-placed stereotactic lesion is comparable in its magnitude of clinical effect to the high frequency electrical stimulation of the same target. Exablate Neuro is intended to treat movement disorders with unilateral ablation of targets in the thalamus, subthalamic nucleus and globus pallidus nuclei. With the ExAblate system, transcranial high-intensity focused ultrasound has been coupled with high resolution MRI to provide precise, consistent treatments that can be monitored throughout the procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Subthalamotomy using the ExAblate
Hospital Universitario HM Puerta del Sur
Móstoles, Madrid, Spain
Incidence of Adverse Events (AEs) associated with ExAblate
Incidence of Adverse Events (AEs) associated with ExAblate
Time frame: Month 6 after the subthalamotomy
Severity of Adverse Events (AEs) associated with ExAblate
Severity of Adverse Events (AEs) associated with ExAblate
Time frame: Month 6 after the subthalamotomy
Mean change in the motor MDS-UPDRS
Mean change in the motor MDS-UPDRS (Movement Disorder Scale-Unified Parkinson's Disease Rating Scale) score in both off- and on-medication conditions (when applicable) for both the treated body side and the total motor score. \[Lowest score = 0; Highest score = 52; Best outcome = lower score\]
Time frame: Month 3 and 6 after the subthalamotomy
Mean change in specific PD motor features
Mean change in specific PD motor features of the treated body side (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores \[Movement Disorder Scale-Unified Parkinson's Disease Rating Scale III\].
Time frame: Month 3 and 6 after the subthalamotomy
MDS-UPDRS I score [Movement Disorder Scale-Unified Parkinson's Disease Rating Scale I]
Lowest score = 0; Highest score = 52; Best outcome = lower score
Time frame: Month 3 and 6 after the subthalamotomy
MDS-UPDRS II score [Movement Disorder Scale-Unified Parkinson's Disease Rating Scale II]
Lowest score = 0; Highest score = 52; Best outcome = lower score
Time frame: Month 3 and 6 after the subthalamotomy
UPDRS IV score [Unified Parkinson's Disease Rating Scale IV]
Lowest score = 0; Highest score = 24; Best outcome = lower score
Time frame: Month 3 and 6 after the subthalamotomy
MDS-Non motor rating scale [Movement Disorder Scale]
Lowest score = 0; Highest score = 52; Best outcome = lower score
Time frame: Month 3 and 6 after the subthalamotomy
Quality of life assessment (QoL)
Assessment of QoL by using the instrument PDQ39
Time frame: Month 3 and 6 after the subthalamotomy
Levodopa equivalent dose change usage
Levodopa equivalent dose change usage (milligrams) when applicable
Time frame: Month 3 and 6 after the subthalamotomy
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