Education and Training
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
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).
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Transcranial ExAblate
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
Ages Eligible for Study
22 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Evalina Salas
650-724-4131
Not Recruiting