Bilateral Treatment of Medication Refractory Essential Tremor
Key facts
- Where
- Baltimore, Charlottesville, Columbus, Morgantown, New York, Philadelphia, and Stanford, United StatesSee the 7 sites
Where in United States
- University of MarylandBaltimore, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- The Ohio State University -Wexner Medical CenterColumbus, United StatesNo longer taking part
- West Virginia UniversityMorgantown, United StatesNo longer taking part
- Weill Cornell MedicineNew York, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- Stanford University School of MedicineStanford, United StatesNo longer taking part
Trial details
- Who runs it
- InSightec
- Trial code
- NCT04112381
- Record updated
- 1 May 2025
- Original description
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.Read full original descriptionShow less
A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
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.
Inclusion: 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: Has received anticoagulants within one month of Exablate procedure; Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus; 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; Unstable cardiac status; History of bleeding disorder; Cerebrovascular disease; Active or suspected acute or chronic uncontrolled infection; 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; Behavior(s) consistent with ethanol or substance abuse; Intracranial tumor; Implanted objects in the skull or the brain; Unable to communicate with the investigator and staff.