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

NCT06685510 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-11-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Beijing Pins Medical Co., Ltd

    collaborator INDUSTRY
  • Second Affiliated Hospital of Nanchang University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06685510 on ClinicalTrials.gov