Bilateral Treatment of Medication Refractory Essential Tremor
Bilateral Treatment of Medication Refractory Essential Tremor
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy
 procedure can be performed on both sides of the brain safely and effectively to reduce
 bilateral tremor.
Inclusion Criteria:

 1. Men and women age 22 years or older

 2. Diagnosis of medication-refractory Essential Tremor

 3. Has previously underwent an Exablate index procedure in a clinical trial or in a
 commercial setting at least 9 months prior to enrolling in this trial

 4. Able to communicate sensations during the Exablate thalamotomy procedure

 Exclusion Criteria:

 1. Has experienced any non-transient neurological event or worsening following the
 Exablate index procedure

 2. Presence of unknown or MR unsafe devices anywhere in the body

 3. Non-transient hemiparesis as determined by physical examination

 4. Clinically significant abnormal speech function as determined by a speech pathologist

 5. Pregnant or breastfeeding

 6. Unstable cardiac status

 7. Behavior(s) consistent with ethanol or substance abuse

 8. History of bleeding disorder

 9. Has received anticoagulants within one month of Exablate procedure

 10. Cerebrovascular disease

 11. Intracranial tumor

 12. Active or suspected acute or chronic uncontrolled infection

 13. Has previously had deep brain stimulation or a prior stereotactic ablation of the
 basal ganglia or thalamus

 14. Implanted objects in the skull or the brain

 15. Currently in a clinical trial involving an investigational product or non-approved use
 of a drug or device or in any other type of medical research

 16. Unable to communicate with the investigator and staff