A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- device : Sham Transcranial ExAblate
- device : Transcranial ExAblate
Ages Eligible For Study:
- 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