Clinical trial NCT06685510: The Relation Between the Prognosis of Subthalamic Nucleus Deep Brain Stimulation Surgery by Microlesion Effect and Electrode Position
Official title: The Relation Between the Prognosis of Subthalamic Nucleus Deep Brain Stimulation Surgery by Microlesion Effect and Electrode Position
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Parkinson&#39;s Disease (PD)
Deep Brain Stimulation
Keywords: Parkinson&amp;#39;s disease
Microlesion Effect
Functional Neuroimages
Deep Brain Stimulation
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
Collaborators: name: Beijing Pins Medical Co., Ltd
First posted: 2024-11-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Comparing MLE and DBS efficacy
timeFrame: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery
Secondary outcomes:
measure: Comparison of the efficacy of electrode positions in relation to different positions of the nucleus pulposus
timeFrame: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery
measure: Compare short-term postoperative efficacy with postoperative efficacy after start-up
timeFrame: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery
measure: Compare the difference in the rate of improvement in MDS UPDRS-III scores within the postoperative pre-opening period
timeFrame: From baseline to 24 hours, 48 hours, 7 days ,6 months,one year after surgery
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
References: