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Bilateral Treatment of Medication Refractory Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112381
Recruitment Status : Active, not recruiting
First Posted : October 2, 2019
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
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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.

Condition or disease Intervention/treatment Phase
Essential Tremor Device: Exablate Model 4000 Type 1.0/1.1 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2026

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Exablate Secondary Procedure
Thalamotomy
 Device: Exablate Model 4000 Type 1.0/1.1
Exablate thalamotomy of non tremor dominant side of the brain


Outcome Measures
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Primary Outcome Measures :
  1. Device and procedure related adverse events [ Time Frame: 3 months ]
    rate of adverse events following the Exablate secondary procedure


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women age 22 years or older
  2. Diagnosis of medication-refractory Essential Tremor
  3. 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
  4. Able to communicate sensations during the Exablate thalamotomy procedure

Exclusion Criteria:

  1. Has experienced any non-transient neurological event or worsening following the Exablate index procedure
  2. Presence of unknown or MR unsafe devices anywhere in the body
  3. Non-transient hemiparesis as determined by physical examination
  4. Clinically significant abnormal speech function as determined by a speech pathologist
  5. Pregnant or breastfeeding
  6. Unstable cardiac status
  7. Behavior(s) consistent with ethanol or substance abuse
  8. History of bleeding disorder
  9. Has received anticoagulants within one month of Exablate procedure
  10. Cerebrovascular disease
  11. Intracranial tumor
  12. Active or suspected acute or chronic uncontrolled infection
  13. Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
  14. Implanted objects in the skull or the brain
  15. 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
  16. Unable to communicate with the investigator and staff
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112381


Locations
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United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
United States, Ohio
The Ohio State University - Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
InSightec
More Information
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT04112381    
Other Study ID Numbers: ET005
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases