The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Non-invasive brain intervention using MR-guided focused ultrasound
MR-Center, University Children's Hospital
Zurich, Canton of Zurich, Switzerland
RECRUITINGPrecision of lesioning
Comparison of size and location of sonicaion lesions on MRI with planning coordinates.
Time frame: 3 months
Safety measurements
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time frame: 6 months
Lesion characteristics
Size of lesions as a function of applied energy/temperature.
Time frame: 3 months
Clinical Efficacy
Pain Scores on the Visual Analog Scale following intervention and at follow-up.
Time frame: 1 year
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