Clinical trial: A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor (NCT03253991)

Eligibility criteria:
Inclusion Criteria

          -  Men and women age 22 years or older

          -  A diagnosis of ET as confirmed from clinical history and examination by a neurologist
             or neurosurgeon specialized in movement disorder

          -  Have had an inadequate response to one or two oral doses of medication, per local
             standards. An inadequate medication trial is defined as a therapeutic dose of each
             medication and poor response to drug, or the development of side effects as the
             medication dose is titrated.

          -  Able to communicate sensations during the ExAblate TcMRgFUS treatment

        Exclusion criteria:

          -  Subjects with unstable cardiac status

          -  Severe hypertension (diastolic BP > 100 on medication)

          -  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 (e.g. Gadolinium or
             Magnevist) including advanced kidney disease

          -  Patient with severely impaired renal function

          -  History of abnormal bleeding and/or coagulopathy

          -  History of immunocompromise including those who are HIV positive.

          -  History of intracranial hemorrhage

          -  Cerebrovascular disease (multiple CVA or CVA within 6 months)

          -  Subjects with uncontrolled symptoms and signs of increased intracranial pressure
             (e.g., headache, nausea, vomiting, lethargy, papilledema).

          -  Individuals who are not able or willing to tolerate the required prolonged stationary
             supine position during treatment (can be up to 4 hrs of total table time.)

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

          -  Significant claustrophobia that cannot be managed with mild medication.

          -  Presence of any other neurodegenerative disease such as Parkinson-plus syndromes
             suspected on neurological examination.

          -  Presence of significant cognitive impairment

          -  Subjects with life-threatening systemic disease

          -  Subjects with a history of seizures within the past year

          -  Subjects with presence or history of psychosis
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 99 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