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The purpose of the study is to evaluate the effectiveness of the Medtronic Adaptive DBS therapy (aDBS) for Parkinson's Disease in China with the Percept family of Implantable Neurostimulators (Percept PC and Percept RC).
The ADAPT-PD China Study will utilize both Dual and Single Threshold aDBS modes (algorithms). Prospective, multicenter, open label comparison (with single-blind aDBS mode from aDBS randomization to evaluation phase), single arm clinical trial designed to evaluate the effectiveness of the Medtronic Adaptive DBS therapy (aDBS) for Parkinson's Disease in China with the Percept family of Implantable Neurostimulators (Percept PC and Percept RC).
The study is expected to be conducted at approximately 5 centers located in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm who received aDBS "Best" Mode (Dual or Single Threshold ) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perceptâ„¢ PC and Percept RC with Adaptive DBS (aDBSâ„¢) | Device | Subjects for whom meet the LFP screening criteria and can be acceptably configured on the "Best" aDBS mode (Dual or Single Threshold) will receive "Best" Mode aDBS treatment and enter the aDBS Evaluation Phase. |
| Measure | Description | Time Frame |
|---|---|---|
| "On" time without troublesome dyskinesia (i.e. Good "On" Time) | Proportion of aDBS subjects meet a success criterion relative to stable cDBS.The success criterion: no worse than 2 hours/day less of "On" time without troublesome dyskinesia (i.e. Good "On" Time) during aDBS compared to cDBS. | From the cDBS baseline to aDBS evaulation phase at about 1 month |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the Adverse Event among the Participants | To characterize:
| From enrollment to the end of treatment at around 12 months to 17.5 months |
Inclusion Criteria:
General (Assessed at Enrollment Visit):
LFP Screening Inclusion Criteria (Conducted during LFP Screening Visit):
1. Subject has Alpha - Beta band (8-30 Hz) amplitude ≥ 1.2 μVp detected on either left and/or right DBS leads on sensing channels 0-2, 0-3, 1-3, 8-10, 8-11, or 9-11.
Exclusion Criteria:
General (Assessed at the Enrollment Visit):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Zhang, Principle Clinical Research Specialist | Contact | +86 18612318110 | jane.zhang7@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Alex Xie, Clinical Research&Medical Science Director | Medtronic (Shanghai) Management Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Recruiting | Beijing | Beijing Municipality | China |
Due to the personal data protection, the IPD for each site will only be used for this study purpose and will only be opened for site investigators. Also, the informed consent doesn't include sharing IPD with other researchers.
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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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|
| Sun Yat-sen Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| West China Hospital | Recruiting | Chengdu | Sichuan | China |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |