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

Neurologic Manifestations Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03935581
• Other study ID #: ET004
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2021
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Neurologic Manifestations
• Tremor
• Tremor, Essential

Intervention

Device:
• ExAblate
Auto Focusing (AF) echo imaging

Locations

Country	Name	City	State
Canada	Sunnybrook	Toronto	Ontario
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul	Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Countries where clinical trial is conducted

Canada,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Device and Procedure related Adverse Events		Treatment through 1 month