Status:
COMPLETED
Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors
Lead Sponsor:
InSightec
Conditions:
Essential Tremor
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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-refractor...
Detailed Description
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-invasiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02289560
Start Date
April 1 2015
End Date
March 10 2023
Last Update
July 3 2024
Active Locations (7)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
The Ohio State Wexner Medical Center
Columbus, Ohio, United States, 43210