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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
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE September 30, 2019
First Posted Date  ICMJE October 2, 2019
Last Update Posted Date October 25, 2021
Actual Study Start Date  ICMJE June 30, 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
Device and procedure related adverse events [ Time Frame: 3 months ]
rate of adverse events following the Exablate secondary procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Bilateral Treatment of Medication Refractory Essential Tremor
Official Title  ICMJE A Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Essential Tremor
Intervention  ICMJE Device: Exablate Model 4000 Type 1.0/1.1
Exablate thalamotomy of non tremor dominant side of the brain
Study Arms  ICMJE Experimental: Exablate Secondary Procedure
Intervention: Device: Exablate Model 4000 Type 1.0/1.1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 8, 2021)
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2019)
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04112381
Other Study ID Numbers  ICMJE ET005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party InSightec
Original Responsible Party Same as current
Current Study Sponsor  ICMJE InSightec
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InSightec
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP