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

InSightec

Status: Unknown

Conditions: Tremor; Neurologic Manifestations; Tremor, Essential

Treatments: Device: ExAblate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03935581

ET004

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ExAblate 4000 System

Experimental group

Description:

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

Treatment:

Device: ExAblate