Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Trial ID or NCT#
NCT02289560,33550
Status
NOT RECRUITING
Purpose
The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).
Official Title
A Continued Access 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
Contact us to find out if this trial is right for you.
Contact
Evalina Salas
650-724-4131
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