A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

Phase 3

• Conditions: Medication Refractory Essential Tremor

• Registration Number: JPRN-UMIN000019498
• Lead Sponsor: Department of Neurosurgery, Osaka University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-27
• Study Completion: 2017-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects with unstable cardiac status 2. Subjects exhibiting any behaviors consistent with ethanol or substance abuse 3. Severe hypertension 4. Subjects with standard contraindications for MR imaging. 5. Known intolerance or allergies to the MRI contrast agent. 6. Patient with severely impaired renal function or who is on dialysis 7. History of abnormal bleeding or coagulopathy. 8. Receiving anticoagulant or antiplatelet therapy within one week, or drugs 9. Active or suspected acute or chronic uncontrolled infection 10. History of immunocompromise. 11. History of intracranial hemorrhage 12. Cerebrovascular disease 13. Subjects with uncontrolled symptoms and signs of increased intracranial pressure. 14. Individuals who are not able or willing to tolerate the required prolonged stationary supine position. 15. Are participating or have participated in another clinical trial 16. Significant claustrophobia 17. Subjects unable to communicate. 18. Presence of any other neurodegenerative disease such as Parkinson plus syndromes 19. Anyone suspected to have the diagnosis of idiopathic Parkinson's disease. 20. Presence of significant cognitive impairment 21. Subjects with life threatening systemic disease 22. Subjects with a history of seizures 23. Subjects with presence or history of psychosis or active mood disorders will be excluded. 24. Subjects with risk factors for intraoperative or postoperative bleeding. 25. Subjects with brain tumors 26. Pregnancy or lactation. 27. Legal incapacity or limited legal capacity. 28. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia 29. Subjects who have been administered botulinum toxins 30. Subjects who have an Overall Skull Density Ratio of 0.3 or less as calculated from the screening CT. 31. Any illness that in the investigator's opinion preclude participation in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified