Bilateral Treatment of Medication Refractory Essential Tremor
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04112381 |
Recruitment Status :
Recruiting
First Posted : October 2, 2019
Last Update Posted : January 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Tremor | Device: Exablate Model 4000 Type 1.0/1.1 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A 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 |

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 |
- Device and procedure related adverse events [ Time Frame: 3 months ]rate of adverse events following the Exablate secondary procedure

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

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
United States, Maryland | |
University of Maryland | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Charlene Aldrich 410-328-5332 cladrich@som.umaryland.edu | |
Principal Investigator: Howard Eisenberg, MD | |
United States, New York | |
Weill Cornell Medicine | Recruiting |
New York, New York, United States, 10065 | |
Contact: Marissa Michael 212-746-7373 mam4001@med.cornell.edu | |
Contact: Sophie O'Bryan 212-746-1788 soo4001@med.cornell.edu | |
Principal Investigator: Michael Kaplitt, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Keren Somers 215-829-6720 keren.somers@pennmedicine.upenn.edu | |
Contact: Marie Kerr 215-829-6720 kerrm@uphs.upenn.edu | |
Principal Investigator: Gordon Baltuch, MD, PhD | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Matthew Patterson 434-243-7336 mwp5f@virginia.edu | |
Principal Investigator: W. Jeff Elias, MD |
Responsible Party: | InSightec |
ClinicalTrials.gov Identifier: | NCT04112381 |
Other Study ID Numbers: |
ET005 |
First Posted: | October 2, 2019 Key Record Dates |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Tremor Essential Tremor Dyskinesias Neurologic Manifestations |
Nervous System Diseases Movement Disorders Central Nervous System Diseases |