ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Trial ID or NCT#
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).
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
- - 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
- - 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