Clinical trial: Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor (NCT03935581)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment