The Relation Between the Prognosis of Subthalamic Nucleus Deep Brain Stimulation Surgery by Microlesion Effect and Electrode Position
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparing MLE and DBS efficacy
研究概览
简要总结
BACKGROUND: Parkinson's disease (PD) is a common movement disorder whose main symptoms include resting tremor, rigidity and bradykinesia. Deep Brain Stimulation (DBS) has become one of the most effective treatments for PD by implanting electrodes in specific deep brain nuclei to alleviate motor symptoms in PD patients. During the implantation of electrodes in the DBS procedure, small lesions produced are known as the Microlesion Effect, which disappears within a short period. The MLE efficacy is positively correlated with the overall efficacy of DBS, but whether the MLE efficacy is affected by the symptoms has not yet been investigated, and a large-sample study is needed to further validate this. This study aims to examine the relationship between electrode implantation location and the prediction of MLE efficacy produced by STN-DBS surgery in PD patients, assess the correlation between electrode implantation location and DBS efficacy in PD patients, and analyze the role of brain networks in the process. The study will also analyze the relationship between micro-destructive effects and long-term DBS efficacy, providing more effective efficacy prediction and a more accurate selection of electrode implantation locations for DBS treatment in PD patients. This study will guide the clinical practice of DBS treatment in PD patients and provide an important reference for future research in related fields.
Object: Primary Parkinson's Disease patients between the ages of 18 and 75 years who meet STN-DBS surgery criteria Aim: To observe the relationship between predicted efficacy and implantation location of STN-DBS for MLE in PD surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson Disease
- •Age from 18 to 80 years old
- •Performed bilateral STN-DBS
排除标准
- •Does not meet STN-DBS surgical criteria
- •Patients with severely offset electrode implantation position (imaging)
- •Not fulfilling the criteria for an arbitrary cohort under exposure conditions;
- •Patients who are unable to voluntarily sign an informed consent form;
- •Patients who do not agree to cooperate with follow-up visits
结局指标
主要结局
Comparing MLE and DBS efficacy
时间窗: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery
Based on the improvement rate of short-term postoperative MDS UPDRS-III scores compared with baseline MDS UPDRS-III scores, three subgroups were divided within each cohort into the \<20% group, the 20%-40% group, and the \>40% group. General statistical analyses of MDS UPDRS-III scores were performed for each subgroup within each cohort, and the mean and standard deviation were calculated. Pearson correlation coefficient analysis was performed on the MDS UPDRS-III score data. Data on MDS UPDRS-III scores of different subgroups within different cohorts were normalized to include short-term postoperative MDS UPDRS-III scores as an independent variable and postoperative post-start-up MDS UPDRS-III scores as a dependent variable, and to include baseline period, postoperative post-start-up, postoperative 6-months, and 12-months MDS UPDRS-III score as a covariate, ANCOVA was performed to observe the differences and correlations of each data node.
次要结局
- Comparison of the efficacy of electrode positions in relation to different positions of the nucleus pulposus(From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery)
- Compare short-term postoperative efficacy with postoperative efficacy after start-up(From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery)
- Compare the difference in the rate of improvement in MDS UPDRS-III scores within the postoperative pre-opening period(From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery)