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

Обзор

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

Вмешательства

• Другое 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
• Другое 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
• Другое 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
• Другое 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
• Другое the score of UPDRS item
  Sum of MDS UPDRS 4.1-4.2 scores greater than or equal to 3

Первичные конечные точки

• Comparing MLE and DBS efficacy [Срок оценки: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery]

Вторичные конечные точки (3)

• Comparison of the efficacy of electrode positions in relation to different positions of the nucleus pulposus [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Nanchang University — Nanchang

Публикации

• 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

Идентификаторы

NCT: NCT06685510 · LC23DBSIIT-HW02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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