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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2021-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Tremor, Essential Neurologic Manifestations Tremor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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ExAblate 4000 System

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

Group Type EXPERIMENTAL

ExAblate

Intervention Type DEVICE

Auto Focusing (AF) echo imaging

Interventions

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ExAblate

Auto Focusing (AF) echo imaging

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No