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Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Trial ID or NCT#
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
- - 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
Investigator(s)
Contact us to find out if this trial is right for you.
CONTACT
Evalina Salas
(650) 724-4131
View on ClinicalTrials.gov
About this Clinical Trial
Your Message Will Go To
Evalina Salas650-724-4131