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Predictive Factors of Short/Long-term Outcome and Complications of Bilateral DBS in PD (PREDIMPSTIM)

2019年1月28日 更新者:University Hospital, Grenoble

Étude Des Facteurs prédictifs Des Effets Cliniques et Des Complications à Court et Long Terme de la Stimulation cérébrale Profonde Des Noyaux Sous-thalamiques Dans la Maladie de Parkinson

The purpose and main objective of this study is the research of pre-operative and operative predictive factors of short-term (1-year) and long-term (15-years) improvement of quality of life, motor and non-motor symptoms in Parkinson's disease patients who have undergone to bilateral Subthalamic Nucleus Deep Brain Stimulation.

The hypothesis of the study is that the definition of pre-operative and operative predictive factors could be able to improve the pre-operative prognostic accuracy of outcome and complications after surgery, allowing also a better selection of the most suitable candidates for bilateral Subthalamic Nucleus Deep Brain Stimulation.

For example, we can suppose that an older age at surgery, elevated axial score, a less preoperative dopa-responsiveness, the presence of mild executive dysfunction at surgery or an unfavourable social status, could negatively influence the short and long term surgery outcome

研究概览

地位

完全的

详细说明

Subthalamic NucleusDeep Brain Stimulation (STN-DBS) represents a short and long-term effective treatment in Parkinson's disease (PD) patients. Various randomized controlled trials have confirmed the superiority of STN-DBS compared to the best medical treatment in patients with advanced Parkinson disease in term of improvement of motor function and quality of life. On the other hand, STN- DBS is associated with an increased risk of adverse events compared to best medical treatment.

Data from previous meta-analysis have shown that only pre-operative dopa-responsiveness can predict the clinical efficacy and outcome of STN-DBS. In particular the improvement of STN-DBS on quality of life mainly concern the physical aspects of functioning with a lower improvement on social and cognitive aspects.

However, not all of PD symptoms respond similarly to STN-DBS. In particular the effects of STN-DBS on the so-called levodopa unresponsive symptoms (i.e. gait and balance symptoms, autonomic dysfunction, sleep disorders, cognitive decline and speech and swallowing troubles) are modest or absent. Furthermore, levodopa unresponsive symptoms are one of the main causes of impairment and disability in advanced PD patients. Bearing in mind these informations, the clinical phenotyping of candidates for surgery appear crucial for the prediction of DBS outcome and selection of better candidates. In the recent years, several papers highlighted and expanded the list of possible predictive factors, from a motor point of view to non-motor symptoms and psychosocial aspects.

In this setting, the aim of our study is to determine the pre-operative and operative short-term (1-year) and long-term (15-years) predictive factors of improvement of quality of life and motor and non-motor symptoms in a large cohort of PD patients who have undergone to bilateral STN-DBS. The better definition of short-term and long-term predictive factors and its association with the different PD different clinical phenotypes could allow in the future a better definition of the effects of STN-DBS on quality of life and motor and non-motor symptoms in the different PD clinical phenotypes.

In the same way, it could be assumed that a better definition of pre-operative predictive factors of surgical, hardware and stimulation-induced STN-DBS side effects in the short term, could also allow a better definition of the risk-to-benefit ratio and outcome after STN-DBS surgery

研究类型

观察性的

注册 (实际的)

420

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Grenoble、法国、38043
        • Moro

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patient with Parkinson's disease treated with bilateral Subthalamic Nucleus Deep Brain Stimulation

描述

Inclusion Criteria:

  • Patients with Parkinson's disease treated with bilateral Subthalamic Nucleus Deep Brain Stimulation

Exclusion Criteria:

  • Patients treated with bilateral Subthalamic Nucleus Deep Brain Stimulation not affected by Parkinson's Disease
  • Patients with Parkinson's disease treated with unilateral Subthalamic Nucleus Deep Brain Stimulation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Changes in the Unified Parkinson's Disease Rating Scale (UPDRS) section I, II, III, IV, V, VI scores
大体时间:pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation
The Unified Parkinson's Disease Rating Scale (UPDRS) has been developed for the clinical evaluation of Parkinson's disease (PD) patients. It allows the assessment of both motor and non-motor symptoms associated with PD
pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation

次要结果测量

结果测量
措施说明
大体时间
Number of Patients that developed Treatment-Related (drug-related or DBS-related) complications
大体时间:1 year after bilateral Subthalamic Nucleus Deep Brain Stimulation

Surgical-related complications, post-operative complications related to DBS devices and hardware, complications related to STN stimulation or drug administration.

Post-operative complications directly related to STN stimulation.

1 year after bilateral Subthalamic Nucleus Deep Brain Stimulation
Changes in the Parkinson's Disease Questionnaire (PDQ-39) total score and different subscale scores (Mobility; Activities of daily living; Emotional well being; Stigma; Social Support; Cognitions; Communication; Bodily discomfort)
大体时间:pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation
The Parkinson's Disease Questionnaire (PDQ-39) is a short 39 item self-report health status questionnaire developed for evaluate the quality of life in Parkinson's disease patients.
pre-operative evaluation, 1-year and 15-years after Subthalamic Nucleus Deep Brain Stimulation
Changes in the Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II, III, IV scores
大体时间:pre-operative evaluation, 1-year after Subthalamic Nucleus Deep Brain Stimulation
The Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is the recent version of the UPDRS revised by the MDS. It allows the assessment of both motor and non-motor symptoms associated with PD
pre-operative evaluation, 1-year after Subthalamic Nucleus Deep Brain Stimulation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Francesco Cavallieri, MD、Chu Grenoble Alpes
  • 研究主任:Elena Moro, MD, PhD、Chu Grenoble Alpes

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年9月11日

初级完成 (实际的)

2018年5月4日

研究完成 (实际的)

2019年1月27日

研究注册日期

首次提交

2017年11月14日

首先提交符合 QC 标准的

2018年5月4日

首次发布 (实际的)

2018年5月17日

研究记录更新

最后更新发布 (实际的)

2019年1月29日

上次提交的符合 QC 标准的更新

2019年1月28日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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