The Relation Between the Prognosis of Subthalamic Nucleus Deep Brain Stimulation Surgery by Microlesion Effect and Electrode Position (Microlesion Ef)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Deep Brain Stimulation; Parkinson's Disease (PD)
• Intervention / Treatment: Other: the score of UPDRS item; Other: the score of UPDRS item; Other: the score of UPDRS item; Other: the score of UPDRS item; Other: the score of UPDRS item

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University
• Collaborators: Beijing Pins Medical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: November 10, 2024
• First Posted (Estimated): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 10, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Parkinson's disease; Microlesion Effect; Functional Neuroimages
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: LC23DBSIIT-HW02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No