Bilateral Treatment of Medication Refractory Essential Tremor
Primary Purpose
Essential Tremor
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exablate Model 4000 Type 1.0/1.1
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor
Eligibility Criteria
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
Sites / Locations
- Stanford University, School of Medicine
- University of Maryland
- Weill Cornell Medicine
- The Ohio State University - Wexner Medical Center
- University of Pennsylvania
- University of Virginia
- West Virginia University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exablate Secondary Procedure
Arm Description
Thalamotomy
Outcomes
Primary Outcome Measures
Device and procedure related adverse events
rate of adverse events following the Exablate secondary procedure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04112381
Brief Title
Bilateral Treatment of Medication Refractory Essential Tremor
Official Title
A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exablate Secondary Procedure
Arm Type
Experimental
Arm Description
Thalamotomy
Intervention Type
Device
Intervention Name(s)
Exablate Model 4000 Type 1.0/1.1
Intervention Description
Exablate thalamotomy of non tremor dominant side of the brain
Primary Outcome Measure Information:
Title
Device and procedure related adverse events
Description
rate of adverse events following the Exablate secondary procedure
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The Ohio State University - Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bilateral Treatment of Medication Refractory Essential Tremor
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