Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor
Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor
The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF)
 echo imaging using the ExAblate Neuro system
This clinical investigation is a feasibility study designed to evaluate the safety and
 feasibility of the ExAblate Neuro system to perform AF echo imaging in patients diagnosed
 with idiopathic Essential Tremor. during the standard care procedure for ET, patients will be
 injected with Definity microbubbles which will enable the ExAblate Neuro system to perform
 the AF imaging.
Inclusion Criteria:

 1. Male or Female age 22 years or older

 2. Able and willing to give consent and able to attend all study visits

 3. A confirmed diagnosis of Essential Tremor resistant to medication therapy

 4. Able to fit into MRI unit

 5. Able to tolerate the procedure with or without some form of sedation

 6. Able to communicate sensations during the ExAblate MRgFUS procedure

 7. Able to activate Stop Sonication button during the ExAblate MRgFUS procedure

 Exclusion Criteria:

 1. Presence of unknown or MRI unsafe devices anywhere in the body.

 2. Patients with known intolerance or allergies to the MRI contrast agents

 3. Women who are pregnant

 4. Patients with advanced kidney disease or on dialysis

 5. Significant cardiac disease or unstable hemodynamic status

 6. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse

 7. History of a bleeding disorder

 8. Patients receiving anticoagulant or drugs known to increase risk of hemorrhage

 9. Patients with cerebrovascular disease

 10. Patients with brain tumors

 11. Individuals who are not able or unwilling to tolerate the required prolonged
 stationary position during treatment (approximately 2-3 hours)

 12. Patients who are currently participating in another clinical investigation

 13. Patients unable to communicate with the investigator and staff

 14. Patients who have cardiac shunts

 15. Patients with relative contraindications to Definity ultrasound contrast agent
 including subjects with a family or personal history of arrhythmia's

 16. Patients with chronic pulmonary disorders

 17. Patients with a history of drug allergies, uncontrolled asthma or hay fever

 18. Patients who have had deep brain stimulation or a prior neuroablative procedure

 19. Women who are pregnant or nursing

 20. Patients who have been administered botulinum toxins into the arm, neck, or face for 5
 months prior to enrollment in the study.