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

NCT06685510 | Enrolling By Invitation DMC

• 1 other identifier: LC23DBSIIT-HW02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson's Disease (PD); Deep Brain Stimulation

Keywords

Parkinson's disease; Microlesion Effect; Functional Neuroimages; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Idiopathic Parkinson Disease
• Age from 18 to 80 years old
• Performed bilateral STN-DBS

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• Beijing Pins Medical Co., Ltd: collaborator

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

Related Publications (1)

• 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.

  PMID: 41109904 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: November 6, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)