A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Not Applicable
- Conditions
- Essential tremor
- Registration Number
- JPRN-UMIN000010714
- Lead Sponsor
- Tokyo Women's Medical University Shin-yurigaoka General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
Unstable cardiac status Severe hypertension (diastolic BP > 100 on medication) Standard contraindications for MR imaging Severely impaired renal function History of abnormal bleeding and/or coagulopathy History of intracranial hemorrhage Infectioous or immunocompromise state Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment Presence of any other neurodegenerative disease or Parkinsonism Presence of significant cognitive impairment as determined with a score ≤ 24 on the Mini Mental Status Examination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tremor improvement and evaluation of advers effect 12 months after treatment
- Secondary Outcome Measures
Name Time Method