Deep Brain Stimulation, Parkinson's Disease (PD)
Conditions
Keywords
Parkinson's disease, Microlesion Effect, Functional Neuroimages, Deep Brain Stimulation
Brief summary
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
Interventions
OTHERthe score of UPDRS item
The score of MDS-UPDRS item 3.1 greater or equal to 2 during the drug-off period at baseline
Sponsors
Beijing Pins Medical Co., Ltd
Second Affiliated Hospital of Nanchang University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Idiopathic Parkinson Disease 2. Age from 18 to 80 years old 3. Performed bilateral STN-DBS
Exclusion criteria
1. Does not meet STN-DBS surgical criteria 2. Patients with severely offset electrode implantation position (imaging) 3. Not fulfilling the criteria for an arbitrary cohort under exposure conditions; 4. Patients who are unable to voluntarily sign an informed consent form; 5. Patients who do not agree to cooperate with follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing MLE and DBS efficacy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
China
Outcome results
None listed