The primary objective of this prospective, multicenter, double-blind, randomized, crossover clinical trial is to evaluate whether Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) is more effective than Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) in improving motor symptoms of patients with Parkinson's disease at 90 days post-treatment.
The primary objective of this prospective, multicenter, double-blind, randomized crossover controlled clinical trial is to evaluate whether STN-DBS provides superior efficacy over GPi-DBS in improving motor symptoms of Parkinson's disease patients at 90 days post-treatment. Randomization of this study is generated by a centralized Contract Research Organization (CRO). At the second follow-up visit, patients will be assigned according to the randomization code list in the system, with each patient first receiving either STN-DBS or GPi-DBS. The randomization ratio between the two groups is 1:1. At the third follow-up visit, each group will then receive stimulation at the other target. Assessments of motor function, cognitive level, anxiety and depression status, and quality of life will be conducted preoperatively. The device will be activated 30 days postoperatively. Target adjustments, along with assessments of motor function, cognitive level, anxiety and depression status, quality of life, and adverse events, will be performed at 120, 210, and 300 days postoperatively. The grouping information will only be known to the operating surgeons and programming physicians, while other investigators, assessing physicians, and patients will remain blinded. This study will be completed within 24 months, enrolling 86 patients from 7 centers in China, with 43 patients in each group. The Data Safety Monitoring Board (DSMB) will conduct regular monitoring to ensure the safe conduct of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232). Participants will receive the STN target stimulation protocol for a 3-month treatment period.
The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232). Participants will receive the GPi target stimulation protocol for a 3-month treatment period.
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Unified Parkinson's Disease Rating Scale Part III (UPDRS III) score
The differences in UPDRS III scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) or Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) treatment. Doctors conducted double-blind evaluations based on this scoring scale. The Unified Parkinson's Disease Rating Scale Part III (UPDRS III) has a scoring range of 0 to 108 points, with higher scores indicating more severe motor symptoms in patients with Parkinson's disease.
Time frame: Before surgery and 90 days (±7 days) after surgery
Freezing of Gait Questionnaire (FOG-Q) score
Description: The differences in FOG-Q scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) or Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) treatment. Doctors conducted evaluations based on this scoring scale. The Freezing of Gait Questionnaire (FOG-Q) has a scoring range of 0 to 24 points, with higher scores indicating more severe freezing of gait symptoms.
Time frame: Before surgery and 90 days (±7 days) after surgery
Berg Balance Scale (BBS) score
Description: The differences in BBS scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received STN-DBS or GPi-DBS treatment. Doctors conducted evaluations based on this scoring scale. The Berg Balance Scale (BBS) has a scoring range of 0 to 56 points, with higher scores indicating better balance function.
Time frame: Before surgery and 90 days (±7 days) after surgery
Unified Dyskinesia Rating Scale (UDysRS) score
The differences in UDysRS scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received STN-DBS or GPi-DBS treatment. Doctors conducted evaluations based on this scoring scale. The Unified Dyskinesia Rating Scale (UDysRS) has a scoring range of 0 to 104 points, with higher scores indicating more severe dyskinesia symptoms.
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The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232). After participants receive 3 months of STN target monotherapy and 3 months of GPi target monotherapy sequentially, they will be administered the combined STN + GPi target stimulation protocol. Prior to the initiation of simultaneous STN + GPi stimulation, participants are required to turn off the stimulator for 4 hours to eliminate the residual effects of the previous target stimulation.
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Time frame: Before surgery and 90 days (±7 days) after surgery
Mini-Mental State Examination (MMSE) score
The differences in MMSE scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received STN-DBS or GPi-DBS treatment. Doctors conducted evaluations based on this scoring scale. The Mini-Mental State Examination (MMSE) has a scoring range of 0 to 30 points, with higher scores indicating better cognitive function.
Time frame: Before surgery and 90 days (±7 days) after surgery
Montreal Cognitive Assessment (MoCA) score
The differences in MoCA scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received STN-DBS or GPi-DBS treatment. Doctors conducted evaluations based on this scoring scale. The Montreal Cognitive Assessment (MoCA) has a scoring range of 0 to 30 points, with higher scores indicating better cognitive function (a score ≥26 is considered normal).
Time frame: Before surgery and 90 days (±7 days) after surgery
Hamilton Anxiety Rating Scale (HAMA) score
The differences in HAMA scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received STN-DBS or GPi-DBS treatment. Doctors conducted evaluations based on this scoring scale. The Hamilton Anxiety Rating Scale (HAMA) has a scoring range of 0 to 56 points, with higher scores indicating more severe anxiety symptoms.
Time frame: Before surgery and 90 days (±7 days) after surgery
Hamilton Rating Scale for Depression (HRSD) score
The differences in HRSD scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received STN-DBS or GPi-DBS treatment. Doctors conducted evaluations based on this scoring scale. The Hamilton Rating Scale for Depression (HRSD) has a scoring range of 0 to 52 points, with higher scores indicating more severe depressive symptoms.
Time frame: Before surgery and 90 days (±7 days) after surgery
Parkinson's Disease Questionnaire-39 (PDQ-39) score
The differences in PDQ-39 scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received STN-DBS or GPi-DBS treatment. Patients completed the questionnaire for evaluation. The Parkinson's Disease Questionnaire-39 (PDQ-39) is scored as a summary index (0-156), with higher scores indicating poorer quality of life.
Time frame: Before surgery and 90 days (±7 days) after surgery
Programming parameters
The differences in programming parameters (including Total Electrical Energy Delivered \[TEED\], contact, current, pulse width, and frequency) at 90 days (±7 days) after surgery between Parkinson's disease patients who received STN-DBS or GPi-DBS treatment.
Time frame: 90 days (±7 days) after surgery
Differences in programming parameters and medication under combined stimulation
The differences in programming parameters (including UPDRS III score, TEED, contact, voltage, pulse width, frequency) and medication (Levodopa Equivalent Daily Dose \[LEDD\]) at 90 days (±7 days) after surgery, compared with baseline, in Parkinson's disease patients receiving simultaneous STN-DBS and GPi-DBS treatment.
Time frame: Baseline and 90 days (±7 days) after surgery
Patient preference for stimulation targets
Patient preference for activated stimulation targets under three conditions: STN-DBS alone, GPi-DBS alone, and simultaneous STN-DBS and GPi-DBS.
Time frame: 90 days (±7 days) after surgery