Clinical trial: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors (NCT01827904)

Eligibility criteria:
Inclusion Criteria:

          -  Men and women, age 22 years and older

          -  Subjects who are able and willing to give informed consent and able to attend all
             study visits

          -  Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and
             examination by a neurologist or neurosurgeon specialized in movement disorder

          -  Subject exhibits a significant disability from their ET despite medical treatment

          -  Subjects should be on a stable dose of all ET medications for 30 days prior to study
             entry

          -  Subject is able to communicate sensations during the ExAblate Transcranial procedure

        Exclusion Criteria:

          -  Subjects with unstable cardiac status

          -  Severe hypertension

          -  Subjects with standard contraindications for MR imaging such as non-MRI compatible
             implanted metallic devices including cardiac pacemakers, size limitations, etc.

          -  Known intolerance or allergies to the MRI contrast agent including advanced kidney
             disease or severely impaired renal function

          -  Significant claustrophobia that cannot be managed with mild medication

          -  Current medical condition resulting in abnormal bleeding and/or coagulopathy

          -  Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within
             one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage

          -  History of intracranial hemorrhage

          -  History of multiple strokes, or a stroke within past 6 months

          -  Subjects who are not able or willing to tolerate the required prolonged stationary
             supine position during treatment

          -  Are participating or have participated in another clinical trial in the last 30 days

          -  Subjects unable to communicate with the investigator and staff

          -  Subjects with a history of seizures within the past year

          -  Subjects with brain tumors
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.


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? 1