ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Trial ID or NCT#
NCT01827904
Status
NOT RECRUITING
Purpose
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).
Official Title
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Eligibility Criteria
Ages Eligible for Study: Older than 22 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- * 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
Exclusion Criteria:
- * 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
Investigator(s)
Pejman Ghanouni, MD, PhD
Radiologist
Associate Professor of Radiology (Body MRI) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology
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Contact
Jennifer Lillian Marcellus
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