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Clinical Trials/JPRN-UMIN000033940
JPRN-UMIN000033940
Completed
Phase 3

A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease. - PD001J

Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital0 sites10 target enrollmentSeptember 1, 2018

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Medication-Refractory Tremor Dominant Idiopathic Parkinsons Disease
Sponsor
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Enrollment
10
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 1, 2018
End Date
December 31, 2020
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 1\.Subjects with unstable cardiac status including: 2\.Subjects exhibiting any behavior 3\.Severe hypertension. 4\.Subjects with standard contraindications for MR imaging 5\.Significant claustrophobia that cannot be managed with mild medication. 6\.Current medical condition resulting in abnormal bleeding and/or coagulopathy 7\.Patient with severely impaired renal function with estimated glomerular filtration 8\.Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound 9\.Subjects with risk factors for intraoperative or postoperative bleeding 10 Subjects who have an Overall Skull Density Ratio of 0\.30 or less as calculated from the screening CT.

Outcomes

Primary Outcomes

Not specified

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