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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Changhai Hospital, the Second Military Medical University | UNKNOWN |
| Shenzhen Second People's Hospital | OTHER |
| Zhongnan Hospital |
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The purpose of this study is to demonstrate the safety and effectiveness of the PINS Deep Brain Stimulation (DBS) system, including the G107R/G107 IPG, L305/L306 directional leads, E204 extensions and related system components.
This is a prospective, open label, non-randomized study. The study will evaluate the clinical outcome and possible adverse effects of the directional DBS treatment. The following data will be collected: therapeutic window, Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores, Parkinson's Disease Questionnaire (PDQ-39) summary scores, total electrical energy delivered, the dosage of anti-parkinsonian medications, on time(h/d) without troublesome dyskinesia, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Directional deep brain stimulation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Directional deep brain stimualtion | Device | Directional deep brain stimualtion in the treatment of Parkinson's disease using L305/L306 leads and G107R/G107 implanted pulse generators (Beijing Pins Medical Co.). |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Window | Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. | 1 month post the device implanted |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Function | Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score. | 3 months post device-activation |
| Change in PDQ-39 score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | China | ||||
| Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University |
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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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| OTHER |
| West China Hospital | OTHER |
| Beijing Tsinghua Changgeng Hospital | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| Nanjing Medical University | OTHER |
| Tianjin Medical University General Hospital | OTHER |
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Using the Parkinson's Disease Questionnaire to acquire a score ranging from 0 to 156 as a summary of all subscores from 39 items. The higher score indicates lower quality of life.
| 3 months post device-activation |
| Total Electrical Energy Delivered(TEED) | TEED=(Voltage^2×frequency×pulse width)/impedance×1 s | 3 months post device-activation |
| The dosage of anti-parkinsonian medications | 3 months post device-activation |
| On time(h/d) without troublesome dyskinesia | 3 months post device-activation |
| Adverse events | 3 months post device-activation |
| Beijing |
| China |
| West China Hospital of Sichuan University | Chengdu | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | China |
| Nanjing Brain Hospital Affiliated to Nanjing Medical University | Nanjing | China |
| Changhai Hospital, the Second Military Medical University | Shanghai | China |
| Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University) | Shenzhen | China |
| Tianjin Medical University General Hospital | Tianjin | China |
| Zhongnan Hospital of Wuhan University | Wuhan | China |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |