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The objective of this prospective, single-arm, open-label study is to assess the safety and efficacy of the staged, dual-target(VIM+PTT thalamotomy)to treat Patiensts with Parkinson Disease using transcranial magnetic resonance guided focused ultrasound system ExAblate 4000, InSightec Ltd.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ExAblate Treatment | Experimental | Participants will undergo a VIM and PTT thalamotomy using MRgFUS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial focused ultrasound thalamotomy | Procedure | Thalamotomy Using Exblate |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Device and Procedure Related Adverse Events | The cumulative sum of adverse events was followed through Year 2 of the study | 2 Years post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Rating Scale for Tremor (CRST) | Sum of baseline and follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and Follow Up were calculated at baseline and follow-up visits averaged across subjects. Low scores are better (show improvement). |
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Inclusion Criteria:
Exclusion Criteria:
1. Unstable angina pectoris on medication 2. Subjects with documented myocardial infarction within six months of protocol entry 3. Significant congestive heart failure defined with ejection fraction < 40 4. Subjects with unstable ventricular arrhythmias 5. Subjects with atrial arrhythmias that are not rate-controlled 11. Severe hypertension (diastolic BP > 100 on medication) 12. History of or current medical condition resulting in abnormal bleeding and/or coagulopathy 13. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure 14. Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard 15. Patient with severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis 16. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
17. Significant claustrophobia that cannot be managed with mild medication 18. Subjects who weigh more than the upper weight limit of the MR table and who cannot fit into the MR scanner 19. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment 20. History of intracranial hemorrhage 21. History of multiple strokes, or a stroke within past 6 months 22. Subjects with a history of seizures within the past year 23. Subjects with brain tumors 24. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment 25. Are participating or have participated in another clinical trial in the last 30 days 26. Any illness that in the investigator's opinion preclude participation in this study 27. Subjects unable to communicate with the investigator and staff 28. Pregnancy or lactation 29. Subjects with remarkable atrophy and poor healing capacity of the scalp (> 30% of the skull area traversed by the sonication pathway) will be excluded from this study 30. Subjects who have an overall Skull Density Ration lower than 0.30 as calculated from the screening CT
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin He, MD;Ph.D. | Contact | +8615321206787 | hehnlasa@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Longsheng Pan Professor, MD | Chinese PLA General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment |
| MDS-UPDRS (Movement Disorder Scale-Unified Parkinson's Disease Rating Scale), Part III | MDS-UPDRS III is a scale that assesses all the motor features of PD (akinesia, tremor, rigidity, gait disturbance). Score range between 0 (no presence of motor features) and 132 (maximum score for all items). | Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment |
| Quality of life assessment with PDQ-39 | Quality of life assessment with PDQ-39 (Range 0-156, scores are combined, the higher the score, the greater the level of clinical expression of Parkinson Disease, the worse clinical outcome is) | Baseline,1 Month, 3 Months, 6 Months, 12 Months, 2 Years post treatment |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |