A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects.
- Type of Study
- Neuroscience - Movement Disorders
- Short Description
To test the efficacy of treatment using the ExAblate Transcranial System against a sham control and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor.
- Principal Investigator
- Ryder Gwinn, MD
- Eligibility Notes
Men and women age 22 years or older with a dignosis of essential tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder. This tremor refractory to adequate trials of at least two medications, one of which should be a first line therapy of either propranolol or primidone. Any contradictions for standard MRI, dignosis of unstable cardiac status, or substance abuse will exclude a potential study subject.