跳至主要内容
临床试验/NCT06090682
NCT06090682招募中不适用

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

Tianjin Huanhu Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Montreal Cognitive Rating Scale(MoCA)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Exclusion criteria included patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery.

结局指标

主要结局

Montreal Cognitive Rating Scale(MoCA)

时间窗: December 2023 to December 2026

The Montreal Cognitive Rating Scale was used to assess the overall cognitive status of patients before and after treatment

verbal fluency test (VF)

时间窗: December 2023 to December 2026

VF test was used to assess frontal executive function and related language function

次要结局

  • the third part of the Unified Parkinson's Disease Rating Scale (UPDRS III)(December 2023 to December 2026)

研究者

发起方
Tianjin Huanhu Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guangrui Zhao

Associate Professor

Tianjin Huanhu Hospital

研究点 (1)

Loading locations...

相似试验