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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-06

Study Completion Date

2026-07-01

Brief Summary

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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

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Detailed Description

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Conditions

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Parkinson's Disease (PD) Deep Brain Stimulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

the score of UPDRS item

Sum of MDS UPDRS 4.1-4.2 scores greater than or equal to 3

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No