Neurologic Manifestations, Tremor, Tremor, Essential
Conditions
Keywords
MRgFUS, ExAblate, Essential Tremor, Auto-Focusing Echo Imaging
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.
Interventions
DEVICEExAblate
Auto Focusing (AF) echo imaging
Sponsors
InSightec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Device and Procedure related Adverse Events | Treatment through 1 month |
Countries
Canada, South Korea
Contacts
PRINCIPAL_INVESTIGATORNir Lipsman
Sunnybrook Health Sciences Centre
Outcome results
None listed