Dual-Target MR-guided Focused Ultrasound for Parkinson Disease
The objective of this prospective, single-arm, open-label study is to assess the safety and efficacy of the staged, dual-target(VIM+PTT thalamotomy)to treat Patiensts with Parkinson Disease using transcranial magnetic resonance guided focused ultrasound system ExAblate 4000, InSightec Ltd.
• Men and women age 30 years or older
• Subjects who are able and willing to give informed consent and able to attend all study visits
• Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site
• Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor sub-scale in the ON vs OFF medication state
• Disabling motor clinical features not optimally controlled by an adequate medication prescription. An adequate medication prescription is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated
• Predominant disability from one side of the body (i.e unilateral or markedly asymmetric disease) as determined by movement disorders neurologist and neurosurgeon
• Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
• Subjects are able to communicate sensations during the Exablate Transcranial procedure.
• The thalamus must be apparent on MRI such that targeting of the Vim nucleus can be performed indirectly by measurement from a line connecting the anterior and posterior commissures of the brain.
⁃ Topographic coordinates of the pallidothalamic tract are localizable on Magnetic resonance imaging (MRI) so that it can be targeted by the ExAblate device.
⁃ Subject should have a Screening motor assessment of ≥ 30 while OFF medications on the MDS-UPDRS
⁃ Subject has a baseline CRST Part A score of 2 or above for postural or intention tremor severity in the upper extremity for the contralateral tremor side while on stable medication
⁃ Subject has a baseline CRST Part C score of 2 or above in any one of the items (speaking, eating, drinking, hygiene, dressing, writing, working, and social activities).