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

Not Applicable

• Conditions: Essential Tremor

• Registration Number: JPRN-UMIN000023639
• Lead Sponsor: Departments of Neurology and Neurosurgery, Hokuto Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-12-31
• Study Start: 2017-01-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• 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 and/or who is on dialysis 7. History of abnormal bleeding and/or coagulopathy 8. Receiving anticoagulant or antiplatelet therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage within one month of focused ultrasound procedure 9. Active or suspected acute or chronic uncontrolled infection 10. History of immunocompromise including those who are HIV positive 11. History of intracranial hemorrhage 12. Cerebrovascular disease 13. Subjects with uncontrolled symptoms and signs of increased intracranial pressure 14. Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination 15. Anyone suspected to have the diagnosis of idiopathic Parkinson's disease 16. Presence of significant cognitive impairment 17. Subjects with life-threatening systemic disease 18. Subjects with a history of seizures within the past year 19. Subjects with presence or history of psychosis. Subjects with significant or active mood disorders including depression 20. Subjects with risk factors for intraoperative or postoperative bleeding 21. Subjects with brain tumors 22. Pregnancy or lactation 23. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia 24. Subjects who have been administered botulinum toxins for 5 months prior to Baseline 25. Subjects who have an Overall Skull Density Ratio of 0.35 or less as calculated from the screening CT

Study & Design

• Study Type: Interventional
• Study Design: Not specified