Status:
ACTIVE_NOT_RECRUITING
Bilateral Treatment of Medication Refractory Essential Tremor
Lead Sponsor:
InSightec
Conditions:
Essential Tremor
Eligibility:
All Genders
22+ years
Phase:
NA
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.
Eligibility Criteria
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 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
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04112381
Start Date
June 30 2020
End Date
June 1 2026
Last Update
May 1 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University, School of Medicine
Stanford, California, United States, 94305
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
Weill Cornell Medicine
New York, New York, United States, 10065
4
The Ohio State University - Wexner Medical Center
Columbus, Ohio, United States, 43210