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| Name | Class |
|---|---|
| National Engineering Research Center of Neuromodulation, Tsinghua University | UNKNOWN |
| Beijing Tiantan Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
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Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic adjustment of stimulation parameters to patients' disease fluctuations and state of activity. The purpose of this study is to verify the long-term safety and effectiveness of closed-loop DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS is more effective than conventional open-loop DBS on PD treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral STN DBS Modulation | Experimental | Participants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop DBS stimulation for 24 hours | Other | Continuous closed-loop modulation for 24 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Movement disorders evaluation | Using MDS-UPDRS III rating scale (0-132, the higher score means a worse outcome) and Rush dyskinesia rating scale (0-12, the higher score means a worse outcome) combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition | 1-3 days |
| Sleep Structure Evaluation | Using polysomnography evaluation (sleep efficiency,N1/N2/N3/REM/Wake after sleep onset duration and percentage,arousal index) and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition | 1-3 nights |
| Diary Outcomes in Parkinson's Disease | Using SCOPA-DC (0-87, the higher score means a worse outcome) to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition | 1-3days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Stimulation-related AEs) and Subjective Satisfactory | Number of modulation related Adverse Events or abnormal vital signs. | 1-3days |
| Total Electrical Energy Delivered to patients | To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion |
| Measure | Description | Time Frame |
|---|---|---|
| Neurophysiological changes of STN-LFP in daytime and sleep | Changes of the power and entropy features of delta, theta, alpha, beta and gamma oscillations | at 3,6,9,12,15 months compared to baseline |
| Functional connectivity changes during long-term DBS modulation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weizhi Pan, B.S. | Contact | +86-010-62796172 | neln@mail.tsinghua.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Engineering Research Center of Neuromodulation | Recruiting | Beijing | Beijing Municipality | 100084 | 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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| Beijing Pins Medical Co., Ltd |
| INDUSTRY |
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| Open-loop DBS stimulation for 24 hours | Other | Continuous open-loop modulation for 24 hours |
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| Closed-loop DBS stimulation for 72 hours | Other | Continuous closed-loop modulation for 72 hours |
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| Open-loop DBS stimulation for 72 hours | Other | Continuous open-loop modulation for 72 hours |
|
| 1-3days |
Changes of subcortical and cortical functional connectivity |
| at 3,6,9,12,15 months compared to baseline |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |