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.
Investigators
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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