Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

This study is evaluating a new technique for performing Thalamotomy for tremor control. While
current techniques have possible invasive or radiation effects, the use of ExAblate if
totally non-invasive and without any radiation. After informed consent and screening,
eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1
day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.

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