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Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism

2021年6月24日更新者：Arnaud Lapostolle、Hospital Avicenne

Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism: a Monocentric Cohort Study With Patient Reported Outcome

Dystonia is a disabling symptom affecting both patients with idiopathic Parkinson's disease (PD) and atypical parkinsonism (AP).

Botulinum toxinum (BoNT), by blocking muscle contraction, is a possible treatment for focal dystonia.

The benefit of BoNT treatment has been proven in some focal dystonia associated with PD or AP.

The investigators aim to give an overview of the efficacy of BoNT in a variety of focal dystonia in a large cohort of parkinsonian patients.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

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

法国
- Seine-Saint-Denis
  - Bobigny、Seine-Saint-Denis、法国、93009
    - Avicenne Hospital

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

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients that have been evaluated in the Neurology department of Avicenne Hospital (academic medical center) between september 1st 2017 and february 11th 2021.

Data will be retrospectively collected within the medical records of those patients.

描述

Inclusion Criteria:

Diagnosed Parkinson's disease or Atypical Parkinsonism
Age > 18 years
Reported dystonia
At least 1 injection with Botulinum toxin realized

Exclusion Criteria:

Refusal to participate in the study

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

团体/队列数

队列和干预

团体/队列
Patients with dystonia secondary to atypical Parkinsonism or Parkinson's disease Patients with dystonia secondary to idiopathic Parkinson's disease or atypical parkinsonism and treated with BoNT
Patients with atypical Parkinsonism or Parkinson's disease and no dystonia Patients with idiopathic Parkinson's disease or atypical parkinsonism and without reported dystonia

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
Comparison of the patient reported efficacy of botulinum toxin treatment between PD and AP patients 大体时间：Up to twelve months	Evaluation by the patient of the efficacy of the former injection on an improvement scale ranging from 0 to 100% (minimum value : 0, maximum value : 100, higher scores mean a better outcome) systematically made in routine care during follow up appointment	Up to twelve months

次要结果测量

结果测量	措施说明	大体时间
Comparison of the patient reported duration of improvement after treatment by botulinum toxin between PD and AP patients 大体时间：Up to twelve months	Evaluation by the patient of the duration of the period during which symptoms were improved (in weeks) systematically made in routine care during follow up appointment	Up to twelve months

其他结果措施

结果测量	措施说明	大体时间
Comparison of the patients' age between PD and AP groups 大体时间：Baseline	Age in years of patients from PD and AP groups	Baseline
Comparison of the sex-ratio between PD and AP groups 大体时间：Screening	Percentage of female (%) in PD and AP groups	Screening
Comparison of the patients' duration of disease between PD and AP groups 大体时间：Baseline	Duration of the disease (years since diagnosis of PD or AP) of patients from PD and AP groups	Baseline
Comparison of the patients' severity of the disease between PD and AP groups 大体时间：Baseline	Severity of the disease in both PD and AP groups measured by the Hoehn and Yahr scale (stage 0 to stage 5, a higher score meaning a more severe disease)	Baseline
Comparison of the patients' daily need in levodopa between PD and AP groups 大体时间：Baseline	Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from PD and AP groups	Baseline
Comparison of the percentage of patients treated with an apomorphine pump between PD and AP groups 大体时间：Baseline	Percentage of patients treated with apomorphine (%) in PD and AP groups	Baseline
Comparison of the percentage of patients treated with deep brain stimulation between PD and AP groups 大体时间：Baseline	Percentage of patients treated with deep brain stimulation (%) in PD and AP groups	Baseline
Comparison of the patients' age between patients presenting with dystonia and patients without reported dystonia 大体时间：Baseline	Age in years	Baseline
Comparison of the percentage of patients treated with deep brain stimulation between patients presenting with dystonia and patients without reported dystonia 大体时间：Baseline	Percentage of patients treated with deep brain stimulation (%) in both groups	Baseline
Comparison of the percentage of patients treated with an apomorphine pump between patients presenting with dystonia and patients without reported dystonia 大体时间：Baseline	Percentage of patients treated with apomorphine (%) in both groups	Baseline
Comparison of the patients' daily need in levodopa between patients presenting with dystonia and patients without reported dystonia 大体时间：Baseline	Levodopa equivalent daily dose (in mg, method as described by CL Tomlinson) of patient from both groups	Baseline
Comparison of the severity of the disease between patients presenting with dystonia and patients without reported dystonia 大体时间：Baseline	Severity of the disease in both groups measured by the Hoehn and Yahr scale (stage 0 to stage 5, a higher score meaning a more severe disease)	Baseline
Comparison of the patients' duration of disease between patients presenting with dystonia and patients without reported dystonia 大体时间：Baseline	Duration of the disease (years since diagnosis of AP or PD) of patients	Baseline
Comparison of the sex-ratio between patients presenting with dystonia and patients without reported dystonia 大体时间：Baseline	Percentage of female (%)	Baseline
Comparison of the dystonia's characteristics between PD and AP groups : muscle affected 大体时间：Day 0	Muscle affected by dystonia (described with International Anatomical Terminology)	Day 0
Comparison of the dystonia's characteristics between PD and AP groups : duration of dystonia 大体时间：Day 0	Duration of the dystonia (years since first report of the dystonia)	Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : dose 大体时间：Day 0	Dose of BoNT used (in mL)	Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : type of BoNT 大体时间：Day 0	Type of botulinum toxin used (onabotulinumtoxinA, abobotulinumtoxinA or incobotulinumtoxinA)	Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : site of injection 大体时间：Day 0	Site of injection (described with International Anatomical Terminology)	Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : number of injections 大体时间：Day 0	Number of injection performed during injection appointment	Day 0
Comparison of the characteristics of the botulinum toxin injection between PD and AP groups : usage of electromyographic or ultrasound guidance 大体时间：Day 0	Usage of ultrasound or electromyography to guide BoNT injection	Day 0

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。

赞助

Hospital Avicenne

合作者

Assistance Publique - Hôpitaux de Paris

调查人员

首席研究员：Bertrand Degos, MD,PhD、Hospital AVICENNE

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1日

初级完成 (实际的)

2021年2月11日

研究完成 (实际的)

2021年2月11日

研究注册日期

首次提交

2021年6月6日

首先提交符合 QC 标准的

2021年6月24日

首次发布 (实际的)

2021年7月2日

研究记录更新

最后更新发布 (实际的)

2021年7月2日

上次提交的符合 QC 标准的更新

2021年6月24日

最后验证

2021年6月1日

Efficacy of Botulinum Toxin for the Treatment of Dystonia Associated With Parkinson's Disease and Atypical Parkinsonism