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.
Phase 3
- Conditions
- Medication-Refractory Tremor Dominant Idiopathic Parkinsons Disease
- Registration Number
- JPRN-UMIN000033940
- Lead Sponsor
- Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint measured will be safety of unilateral, 3Tesla, ExAblate Transcranial thalamotomy for TDPD as determined from adverse events recorded during the one year study period.
- Secondary Outcome Measures
Name Time Method