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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
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.
Xuanwu Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen Hospital
Guangzhou, Guangdong, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
"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.
Time frame: From the cDBS baseline to aDBS evaulation phase at about 1 month
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West China Hospital
Chengdu, Sichuan, China