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| Name | Class |
|---|---|
| Beijing Pins Medical Co., Ltd | INDUSTRY |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the score of UPDRS item | Other | The score of MDS-UPDRS item 3.1 greater or equal to 2 during the drug-off period at baseline | ||
| the score of UPDRS item | Other | The score of MDS-UPDRS item 3.3 greater or equal to 2 during the drug-off period at baseline | ||
| the score of UPDRS item | Other | The score of MDS-UPDRS item 3.10 greater or equal to 2 during the drug-off period at baseline | ||
| the score of UPDRS item | Other | Any one of the MDS UPDRS 3.15-3.17 scores greater or equal to 2 during the drug-off period at baseline | ||
| the score of UPDRS item | Other | Sum of MDS UPDRS 4.1-4.2 scores greater than or equal to 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing MLE and DBS efficacy | 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. | From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the efficacy of electrode positions in relation to different positions of the nucleus pulposus | Electrode position reconstruction was performed on all subject imaging data. Improvement rates and mean improvement rates were calculated for MDS UPDRS-III scores in the short-term postoperative period, after postoperative start-up, and at 6 and 12 months postoperatively compared to baseline. MLE regional analyses were performed for each subgroup within each cohort, electrode position efficacy heat maps were calculated, and the heat maps were qualitatively analyzed to discuss the relationship between electrode position and efficacy. |
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Inclusion Criteria:
Exclusion Criteria:
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Idiopathic Parkinson's disease patients who consecutively consulted the Second Affiliated Hospital of Nanchang University's PD-specialized outpatient clinic were collected as the subjects.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41109904 | Derived | Liang L, Zhao J, Wang H, Chen L, Shi Q, Yang X, Ma H, Zhu Y, Li Z, Huang W. The microlesion effect is associated with global cognitive impairment and predicts motor outcomes after subthalamic deep brain stimulation in Parkinson's disease. J Neurol. 2025 Oct 18;272(11):708. doi: 10.1007/s00415-025-13443-z. |
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| 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 | Improvement rates within the cohort were calculated and analyzed with general statistics for short-term postoperative, postoperative boot-up, and postoperative 6-month and 12-month comparisons of baseline MDS UPDRS-III scores, and the mean and standard deviation of the improvement rates within the cohort for postoperative boot-up, and postoperative 6-month and 12-month comparisons of baseline PDQ-39 scores were calculated. Differences in improvement rate mean at each time point within the cohort were compared, and linear regression analyses of improvement rates were performed to qualitatively analyze the relationship between short-term postoperative outcomes and long-term postoperative outcomes after postoperative start-up and postoperatively. | 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 | General statistical analyses of MDS UPDRS-III scores within the cohort, subgroups within the cohort, and subgroups within the subgroups and improvement rates compared to baseline were performed to compare the differences in data between cohorts, subgroups, and subgroups within the cohort, and Pearson's correlation analysis, analysis of variance (ANOVA), and qualitative analyses were used to look at the efficacy of postoperative MLE. | From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery |