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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Neurologic Manifestations; Tremor; Tremor, Essential
• Intervention / Treatment: Device: ExAblate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook
• Korea, Republic of
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 03722
      • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Device and Procedure related Adverse Events	Treatment through 1 month

Collaborators and Investigators

• Sponsor: InSightec
• Investigators: Principal Investigator: Nir Lipsman, Sunnybrook Health Science Centre

Publications and helpful links

General Publications

• Chang KW, Rachmilevitch I, Chang WS, Jung HH, Zadicario E, Prus O, Chang JW. Safety and Efficacy of Magnetic Resonance-Guided Focused Ultrasound Surgery With Autofocusing Echo Imaging. Front Neurosci. 2021 Jan 12;14:592763. doi: 10.3389/fnins.2020.592763. eCollection 2020.
• Jones RM, Huang Y, Meng Y, Scantlebury N, Schwartz ML, Lipsman N, Hynynen K. Echo-Focusing in Transcranial Focused Ultrasound Thalamotomy for Essential Tremor: A Feasibility Study. Mov Disord. 2020 Dec;35(12):2327-2333. doi: 10.1002/mds.28226. Epub 2020 Aug 20.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Essential Tremor; MRgFUS; ExAblate; Auto-Focusing Echo Imaging
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesias; Tremor; Essential Tremor; Neurologic Manifestations
• Other Study ID Numbers: ET004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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