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

Sponsor

InSightec (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03935581

Collaborator

(none)

Enrollment

Locations

Arm

32.2

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Tremor, Essential Neurologic Manifestations Tremor	Device: ExAblate	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 25, 2019

Actual Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of Device and Procedure related Adverse Events [Treatment through 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.