NCT06685510

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	the score of UPDRS item	The score of MDS-UPDRS item 3.1 greater or equal to 2 during the drug-off period at baseline
OTHER	the score of UPDRS item	The score of MDS-UPDRS item 3.3 greater or equal to 2 during the drug-off period at baseline
OTHER	the score of UPDRS item	The score of MDS-UPDRS item 3.10 greater or equal to 2 during the drug-off period at baseline
OTHER	the score of UPDRS item	Any one of the MDS UPDRS 3.15-3.17 scores greater or equal to 2 during the drug-off period at baseline
OTHER	the score of UPDRS item	Sum of MDS UPDRS 4.1-4.2 scores greater than or equal to 3

Timeline

• Start date: 2023-11-06
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: China