exablate transcranial mrgfus for the management of treatment-refractory movement disorders

Conditions: Movement Disorders; Essential Tremor; Holmes Tremor; Parkinson's Disease; Wilson's Disease; Huntington's Disease; Dystonia; Tardive Dyskinesia; Orofacial Dyskinesias

Summary: 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