Bilateral Treatment of Medication Refractory Essential Tremor
Not Applicable
Active, not recruiting
- Conditions
- Essential Tremor
- Registration Number
- NCT04112381
- Lead Sponsor
- InSightec
- Brief Summary
The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
- Men and women age 22 years or older
- Diagnosis of medication-refractory Essential Tremor
- Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
- Able to communicate sensations during the Exablate thalamotomy procedure
Exclusion Criteria
- Has experienced any non-transient neurological event or worsening following the Exablate index procedure
- Presence of unknown or MR unsafe devices anywhere in the body
- Non-transient hemiparesis as determined by physical examination
- Clinically significant abnormal speech function as determined by a speech pathologist
- Pregnant or breastfeeding
- Unstable cardiac status
- Behavior(s) consistent with ethanol or substance abuse
- History of bleeding disorder
- Has received anticoagulants within one month of Exablate procedure
- Cerebrovascular disease
- Intracranial tumor
- Active or suspected acute or chronic uncontrolled infection
- Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
- Implanted objects in the skull or the brain
- Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
- Unable to communicate with the investigator and staff
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Device and procedure related adverse events 3 months rate of adverse events following the Exablate secondary procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Stanford University, School of Medicine
🇺🇸Stanford, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
The Ohio State University - Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Stanford University, School of Medicine🇺🇸Stanford, California, United States