Effect and Mechanism of Brain Stimulation for Parkinson's Disease With Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
This study intends to apply structural and functional brain network neuroimaging techniques combined with image post-processing methods to explore the differences in brain network changes in PD patients with cognitive impairment after DBS or TMS.

Detailed Description
-----------------
A variety of post-processing methods (VBM, SPM, CAT, LEAD-DBS, etc.) were used to analyze structural brain network images (sMRI, DTI) and functional brain network images (rs-fMRI, PET) based on connectomics, and combined with the changes of clinical symptoms before and after treatment. To study the mechanism of the influence of neural regulation on brain network, and further analyze how DBS and TMS improve the cognitive symptoms of PD patients from the perspective of brain connectomics, so as to explore the occurrence and development of Parkinson's disease with cognitive impairment and the possible improvement mechanism.According to the individual differences in clinical symptoms of different PD patients, better stimulation sites and the best brain network are sought to further guide the surgical plan, so as to obtain the best clinical treatment effect.

Official Title
-----------------
Effect and Mechanism of Deep Brain Stimulation and Transcranial Magnetic Stimulation on Parkinson's Disease With Cognitive Impairment

Conditions
-----------------
Parkinson Disease, Cognitive Impairment

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. The clinical diagnosis of PD is consistent with the United Kingdom Parkinson's Disease Society Brain Bank criteria, with disease duration over 5 years, acute levodopa motor response ≥30%, and indication for STN-DBS. Exclusion Criteria: Exclusion criteria included patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery.

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cognitive Impairment (CI) group and No Cognitive Impairment (NCI) group<br>We intend to recruit 200 patients with primary PD to undergo DBS surgery or only TMS treatment according to whether the surgical indication is available. We will observe the changes in cognitive function of patients before and after different brain stimulation treatments. Parkinson's disease patients with cognitive impairment after brain stimulation were divided into cognitive impairment group, and those without cognitive impairment after treatment were divided into no cognitive impairment group | Device: Deep Brain Stimulation(DBS) and Transcranial Magnetic Stimulation(TMS)<br>* We observed the changes in cognitive function of patients before and after different brain stimulation treatments, and further compared the effects of different brain stimulation treatments on cognitive function of PD patients and the related mechanisms according to whether DBS surgery was performed or TMS therapy was given only according to the surgical indications.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Rating Scale(MoCA) | The Montreal Cognitive Rating Scale was used to assess the overall cognitive status of patients before and after treatment | December 2023 to December 2026 | 
| verbal fluency test (VF) | VF test was used to assess frontal executive function and related language function | December 2023 to December 2026 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the third part of the Unified Parkinson's Disease Rating Scale (UPDRS III) | Measures motor symptoms and Higher scores indicate more severe impairment in motor function | December 2023 to December 2026 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, Cognitive Impairment, Deep brain stimulation, Transcranial magnetic stimulation