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Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Not Recruiting
Trial ID: NCT02289560,33550
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
Stanford Investigator(s)
Pejman Ghanouni, MD, PhD
Associate Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery, of Obstetrics and Gynecology and of Urology
Eligibility
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
Intervention(s):
device: Transcranial ExAblate
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Evalina Salas
650-724-4131