跳至主要内容
临床试验/NCT06095245
NCT06095245进行中(未招募)不适用

The Outcome of Subthalamic Deep Brain Stimulation in Advanced Parkinson's Disease and Morphometric Differences

Hospital District of Helsinki and Uusimaa1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
35
试验地点
1
主要终点
The clinical outcome of subthalamic DBS as evaluated with UPDRS III and levodopa equivalent daily dosage changes

研究概览

简要总结

The research will evaluate possible clinical and individual brain topographic features affecting the outcome in subthalamic deep brain stimulation (DBS) with patients with Parkinson's disease (PD). The patient cohort consists 35 PD patients treated with subthalamic DBS in 2020-2022. The clinical features (such as age, disease duration, response to levodopa in the levodopa challenge test) will be evaluated retrospectively from the medical records and brain topographic features from the preoperative 3 Tesla brain imaging.

详细描述

Subthalamic deep brain stimulation (STN-DBS) is known to enhance motor function in advanced Parkinson's disease and to enable a significant reduction of the use of anti-Parkinsonian medication. A levodopa challenge test is considered as a good predictor of DBS outcome, as well as disease duration. There are heterogenous findings on the age effect on DBS outcome. In recent years, the effect of STN's connectivity with other brain areas on DBS outcome have drawn more attention. The study aim was to evaluate, alongside the clinical predictors, the effect of the patients' individual brain topography on DBS outcome.

The medical records of 35 patients with PD was used to analyze DBS outcome measured with the following scales: Unified Parkinson's Disease Questionnaire, use of anti-Parkinsonian medication (LEDD), Abnormal Involuntary Movement Scale, Beck Depression Inventory, Parkinson's Disease Questionnaire 39, Non-Motor Symptoms Questionnaire. The 3 Tesla preoperative brain MRI images were analyzed with MATLAB for morphometric differences.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Advanced Parkinson's disease and subthalamic deep brain stimulation treatment. The DBS screening and operation done in Helsinki University Hospital (HUS)

排除标准

  • Patients with Parkinson's disease and not treated with subthalamic DBS in HUS

结局指标

主要结局

The clinical outcome of subthalamic DBS as evaluated with UPDRS III and levodopa equivalent daily dosage changes

时间窗: 6 months

The UPDRS III scores and levodopa equivalent daily dosage at baseline and at 6-month's visit will be evaluated and the changes will be analyzed as clinical outcome of DBS treatment

次要结局

  • The patients' individual brain tomographic features affecting the DBS outcome(6 months)

研究者

发起方
Hospital District of Helsinki and Uusimaa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maija Koivu

M.D., Specialist in Neurology

Hospital District of Helsinki and Uusimaa

研究点 (1)

Loading locations...

相似试验