Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First STN-DBS group | Experimental | Treatment involves deep brain electrode implantation with the STN target stimulation protocol.Stimulator activation time: To avoid the impact of local cerebral edema and microlesional effects after electrode implantation on clinical efficacy assessment, the STN target stimulator will be activated at the first follow-up visit.Postoperative medication: During the study period, patients are not prohibited from using drug therapy. Existing therapeutic drugs may be adjusted or new drugs for Parkinson's disease may be added.At the second follow-up visit, patients will receive the GPi target stimulation protocol.At the third follow-up visit, patients will receive the simultaneous STN + GPi stimulation protocol.At the final follow-up visit, the most clinically satisfactory stimulation protocol will be selected based on the patient's specific condition.Washout period: All patients will switch to GPi target therapy 90 days after receiving STN target stimulation. |
|
| First GPi-DBS group | Active Comparator | Treatment involves deep brain electrode implantation with the GPi target stimulation protocol.Stimulator activation time: To avoid the impact of local cerebral edema and microlesional effects after electrode implantation on clinical efficacy assessment, the GPi target stimulator will be activated at the first follow-up visit.Postoperative medication: During the study period, patients are not prohibited from using drug therapy. Existing therapeutic drugs may be adjusted or new drugs for Parkinson's disease may be added.At the second follow-up visit, patients will receive the STN target stimulation protocol.At the third follow-up visit, patients will receive the simultaneous STN + GPi stimulation protocol.At the final follow-up visit, the most clinically satisfactory stimulation protocol will be selected based on the patient's specific condition.Washout period: All patients will switch to STN target therapy 90 days after receiving GPi target stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STN-DBS stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before surgery and 90 days (±7 days) after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rujin Wang | Contact | +8618101287707 | reganwang1223@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27527541 | Result | Sidiropoulos C, LeWitt PA, Odekerken VJ, Schuurman PR, de Bie RM. GPi vs STN deep brain stimulation for Parkinson disease: Three-year follow-up. Neurology. 2016 Aug 16;87(7):745-6. doi: 10.1212/WNL.0000000000003027. No abstract available. | |
| 28701061 | Result | Xu H, Zheng F, Krischek B, Ding W, Xiong C, Wang X, Niu C. Subthalamic nucleus and globus pallidus internus stimulation for the treatment of Parkinson's disease: A systematic review. J Int Med Res. 2017 Oct;45(5):1602-1612. doi: 10.1177/0300060517708102. Epub 2017 Jul 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
prospective, multicenter, superiority, double-blind, randomized crossover control.
Not provided
Not provided
Not provided
|
| GPi-DBS stimulation | Device | 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. |
|
| STN&GPi-DBS stimulation | Device | 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. |
|
| 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 90 days (±7 days) after surgery |
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Nanjing Brain Hospital | Nanjing | Jiangsu | 210029 | China |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116011 | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| Changhai Hospital of Shanghai | Shanghai | Shanghai Municipality | 200120 | China |
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | 300350 | China |
|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
|
| 30975618 | Result | Dulski J, Schinwelski M, Konkel A, Grabowski K, Libionka W, Waz P, Sitek EJ, Slawek J. The impact of subthalamic deep brain stimulation on sleep and other non-motor symptoms in Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:138-144. doi: 10.1016/j.parkreldis.2019.04.001. Epub 2019 Apr 5. |
| 29356826 | Result | Ramirez-Zamora A, Ostrem JL. Globus Pallidus Interna or Subthalamic Nucleus Deep Brain Stimulation for Parkinson Disease: A Review. JAMA Neurol. 2018 Mar 1;75(3):367-372. doi: 10.1001/jamaneurol.2017.4321. |
| 25197963 | Result | Okun MS. Deep-brain stimulation--entering the era of human neural-network modulation. N Engl J Med. 2014 Oct 9;371(15):1369-73. doi: 10.1056/NEJMp1408779. Epub 2014 Sep 8. No abstract available. |
| 21419000 | Result | Chen J, Liu JL, Chen X, Qian H, Xian WB, Zhou HY, Liu YM, Ye XF, Zheng YF, Zhang SL, Chen L, Li JR, Liu ZL, Pei Z. [Significant improvement of motor symptoms by deep brain stimulation of bilateral subthalamic nucleus in patients with moderate or advanced Parkinson's disease]. Zhonghua Yi Xue Za Zhi. 2011 Feb 1;91(5):291-5. Chinese. |
| 15465397 | Result | Nova IC, Perracini MR, Ferraz HB. Levodopa effect upon functional balance of Parkinson's disease patients. Parkinsonism Relat Disord. 2004 Oct;10(7):411-5. doi: 10.1016/j.parkreldis.2004.04.004. |
| 10766889 | Result | Bejjani BP, Gervais D, Arnulf I, Papadopoulos S, Demeret S, Bonnet AM, Cornu P, Damier P, Agid Y. Axial parkinsonian symptoms can be improved: the role of levodopa and bilateral subthalamic stimulation. J Neurol Neurosurg Psychiatry. 2000 May;68(5):595-600. doi: 10.1136/jnnp.68.5.595. |
| 24057652 | Result | Ma CL, Su L, Xie JJ, Long JX, Wu P, Gu L. The prevalence and incidence of Parkinson's disease in China: a systematic review and meta-analysis. J Neural Transm (Vienna). 2014 Feb;121(2):123-34. doi: 10.1007/s00702-013-1092-z. Epub 2013 Sep 22. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |