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Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor (ET004)

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. Identifier: NCT03935581
Recruitment Status : Active, not recruiting
First Posted : May 2, 2019
Last Update Posted : September 17, 2021
Information provided by (Responsible Party):

Brief Summary:
The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system

Condition or disease Intervention/treatment Phase
Tremor, Essential Neurologic Manifestations Tremor Device: ExAblate Not Applicable

Detailed Description:
This clinical investigation is a feasibility study designed to evaluate the safety and feasibility of the ExAblate Neuro system to perform AF echo imaging in patients diagnosed with idiopathic Essential Tremor. during the standard care procedure for ET, patients will be injected with Definity microbubbles which will enable the ExAblate Neuro system to perform the AF imaging.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Assessment of Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Idiopathic Essential Tremor With Medication Refractory Tremor
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ExAblate 4000 System
ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor
Device: ExAblate
Auto Focusing (AF) echo imaging

Primary Outcome Measures :
  1. Incidence of Device and Procedure related Adverse Events [ Time Frame: Treatment through 1 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or Female age 22 years or older
  2. Able and willing to give consent and able to attend all study visits
  3. A confirmed diagnosis of Essential Tremor resistant to medication therapy
  4. Able to fit into MRI unit
  5. Able to tolerate the procedure with or without some form of sedation
  6. Able to communicate sensations during the ExAblate MRgFUS procedure
  7. Able to activate Stop Sonication button during the ExAblate MRgFUS procedure

Exclusion Criteria:

  1. Presence of unknown or MRI unsafe devices anywhere in the body.
  2. Patients with known intolerance or allergies to the MRI contrast agents
  3. Women who are pregnant
  4. Patients with advanced kidney disease or on dialysis
  5. Significant cardiac disease or unstable hemodynamic status
  6. Patients exhibiting any behavior(s) consistent with ethanol or substance abuse
  7. History of a bleeding disorder
  8. Patients receiving anticoagulant or drugs known to increase risk of hemorrhage
  9. Patients with cerebrovascular disease
  10. Patients with brain tumors
  11. Individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
  12. Patients who are currently participating in another clinical investigation
  13. Patients unable to communicate with the investigator and staff
  14. Patients who have cardiac shunts
  15. Patients with relative contraindications to Definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's
  16. Patients with chronic pulmonary disorders
  17. Patients with a history of drug allergies, uncontrolled asthma or hay fever
  18. Patients who have had deep brain stimulation or a prior neuroablative procedure
  19. Women who are pregnant or nursing
  20. Patients who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to enrollment in the study.

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 identifier (NCT number): NCT03935581

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Canada, Ontario
Toronto, Ontario, Canada, M4N 3M5
Korea, Republic of
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu, Korea, Republic of, 03722
Sponsors and Collaborators
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Principal Investigator: Nir Lipsman Sunnybrook Health Science Centre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: InSightec Identifier: NCT03935581    
Other Study ID Numbers: ET004
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 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: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by InSightec:
Essential Tremor
Auto-Focusing Echo Imaging
Additional relevant MeSH terms:
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Essential Tremor
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases