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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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Purpose: The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.
Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation | Experimental | DBS Implant and stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation (Beijing PINS Medical Co., Ltd) | Device | PINS Stimulator System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) | Change from Baseline | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Dementia Rating Scale | Change from Baseline | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Fumin, PhD | Contact | +86 13811534875 | pins_medical@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Luming, PhD | Tsinghua University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 301 Hospatl | Recruiting | Beijing | Beijing Municipality | 100853 | China |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |