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Completed NCT03935581

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

Conditions: Tremor, Essential, Neurologic Manifestations, Tremor

Sex: All
Ages: 22 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: InSightec

Location: Sunnybrook Toronto Ontario

Summary

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

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03935581). StuddyBuddy aggregates publicly available trial information.