Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 1/23/2019 |
Start Date: | April 2015 |
End Date: | December 2020 |
A Continued Access Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
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).
treatment using the ExAblate Transcranial System and to further demonstrate safety in
medication-refractory tremor in patients with essential tremor (ET).
This study is evaluating a new technique for performing Thalamotomy for tremor control. While
current techniques have possible invasive or radiation effects, the use of ExAblate if
totally non-invasive and without any radiation. After informed consent and screening,
eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1
day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.
current techniques have possible invasive or radiation effects, the use of ExAblate if
totally non-invasive and without any radiation. After informed consent and screening,
eligible subjects will be undergo an ExAblate treatment. All subjects will be followed at 1
day, 1 week, 1, 3, 6 and 12 months and for up to 5 years as directed by their doctor.
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
We found this trial at
7
sites
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: G. Rees Cosgrove, MD
Phone: 617-732-6826
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Baltimore, Maryland 21201
Principal Investigator: Howard Eisenberg, MD
Phone: 410-328-5332
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: W. Jeff Elias, MD
Phone: 434-243-1435
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Columbus, Ohio 43210
Principal Investigator: Ali Rezai, MD
Phone: 614-366-6639
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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5300 Tallman Ave NW
Seattle, Washington 98122
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Ryder Gwinn, M.D.
Phone: 206-320-3070
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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300 Pasteur Dr
Stanford, California 94305
Stanford, California 94305
(650) 723-4000
Principal Investigator: Pejman Ghanouni, M.D.
Phone: 650-724-4131
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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