ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders

The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients with treatment-refractory symptoms of movement disorders.

The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from movement disorder symptoms:

* FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients suffering from treatment-refractory movement disorders through an intact human skull with a low risk of transient adverse effects as evaluated during follow-up of up to 12-months.
* A pre-defined target volume inside the brain can be accurately ablated, as demonstrated on post-treatment MRI.
* Lesions generated with ExAblate Neuro will result in clinical effects that are similar to those seen with ablative procedures using other surgical techniques (e.g. RF procedure).

Eligibility Criteria:
Inclusion Criteria:

* Men and women, between 18 and 85 years, inclusive.
* Subjects who are able and willing to give consent and able to attend all study visits.
* A movement disorder symptom that has been deemed treatment-refractory by a movement disorder neurologist, including:

  o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus, dyskinesia, spasms, tics
* Medication-refractoriness as determined by an adequate dose and duration of standard movement disorders treatment as determined by a specialist neurologist (e.g. a trial of primidone and propranolol for ET)
* Able to communicate sensations during the ExAblate Neuro treatment
* Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

Exclusion Criteria:

* Patients with unstable cardiac status including:

  * Unstable angina pectoris on medication
  * Patients with documented myocardial infarction within six months of protocol entry
  * Congestive heart failure requiring medication (other than diuretic)
  * Patients on anti-arrhythmic drugs
* Severe hypertension (diastolic BP \> 100 on medication)
* Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
* History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)
* Cerebrovascular disease (multiple CVA or CVA within 6 months)
* Symptoms and signs of increased intracranial pressure (e.g. headache, nausea, vomiting, lethargy, and papilledema)
* Untreated, uncontrolled sleep apnea
* Active or suspected acute or chronic uncontrolled infection
* History of intracranial hemorrhage
* Individuals 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
* Patients unable to communicate with the investigator and staff.
* Presence of any other neurodegenerative disease like multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
* Patients with a history of seizures within the past year
* Patients with psychiatric illness that are not well controlled. Any presence of psychosis will be excluded.
* Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter) or a documented coagulopathy
* Patients with brain tumors
* Any illness that in the investigator's opinion preclude participation in this study.
* Pregnancy or lactation.
* Patient is unable to provide his own consent for any reason.
* Legal incapacity or limited legal capacity.
* Patients who have DBS or a prior stereotactic ablation of the basal ganglia
* History of immunocompromise, including patient who is HIV positive
* Known life-threatening systemic disease