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

Primary Purpose

Tremor, Essential, Neurologic Manifestations, Tremor

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

ExAblate

About this trial

This is an interventional device feasibility trial for Tremor, Essential focused on measuring MRgFUS, ExAblate, Essential Tremor, Auto-Focusing Echo Imaging

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Sunnybrook
Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExAblate 4000 System

Arm Description

ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor

Outcomes

Primary Outcome Measures

Incidence of Device and Procedure related Adverse Events

Secondary Outcome Measures

Full Information

NCT ID

NCT03935581

First Posted

April 18, 2019

Last Updated

September 15, 2021

Sponsor

InSightec

1. Study Identification

Unique Protocol Identification Number

NCT03935581

Brief Title

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

Acronym

ET004

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 25, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InSightec

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tremor, Essential, Neurologic Manifestations, Tremor

Keywords

MRgFUS, ExAblate, Essential Tremor, Auto-Focusing Echo Imaging

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ExAblate 4000 System

Arm Type

Experimental

Arm Description

ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor

Intervention Type

Device

Intervention Name(s)

ExAblate

Intervention Description

Auto Focusing (AF) echo imaging

Primary Outcome Measure Information:

Title

Incidence of Device and Procedure related Adverse Events

Time Frame

Treatment through 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or Female age 22 years or older Able and willing to give consent and able to attend all study visits A confirmed diagnosis of Essential Tremor resistant to medication therapy Able to fit into MRI unit Able to tolerate the procedure with or without some form of sedation Able to communicate sensations during the ExAblate MRgFUS procedure Able to activate Stop Sonication button during the ExAblate MRgFUS procedure Exclusion Criteria: Presence of unknown or MRI unsafe devices anywhere in the body. Patients with known intolerance or allergies to the MRI contrast agents Women who are pregnant Patients with advanced kidney disease or on dialysis Significant cardiac disease or unstable hemodynamic status Patients exhibiting any behavior(s) consistent with ethanol or substance abuse History of a bleeding disorder Patients receiving anticoagulant or drugs known to increase risk of hemorrhage Patients with cerebrovascular disease Patients with brain tumors Individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours) Patients who are currently participating in another clinical investigation Patients unable to communicate with the investigator and staff Patients who have cardiac shunts Patients with relative contraindications to Definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's Patients with chronic pulmonary disorders Patients with a history of drug allergies, uncontrolled asthma or hay fever Patients who have had deep brain stimulation or a prior neuroablative procedure Women who are pregnant or nursing Patients who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to enrollment in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nir Lipsman

Organizational Affiliation

Sunnybrook Health Science Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Yonsei University Health System, Severance Hospital

City

Seoul

State/Province

Seodaemun-gu

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33510610

Citation

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.

Results Reference

derived

PubMed Identifier

32815611

Citation

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.

Results Reference

derived

Learn more about this trial

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

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