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PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1 (PuLsE 2)

2014年10月14日更新者：Cyberonics, Inc.

A Post-Market, Open Observational Long-term Effectiveness Follow-up Study of Participants With Drug-resistant Epilepsy With Partial-onset Seizures Previously Enrolled in a Randomized Controlled Trial (E-100: PuLsE) Comparing Best Medical Practice With or w/o Adjunctive Vagus Nerve Stimulation Therapy

This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

研究概览

地位

完全的

条件

癫痫

详细说明

In 2005 Cyberonics, Inc. initiated PuLsE: an open, prospective, randomized, parallel group study directly comparing Best Medical Practice with and without adjunctive VNS Therapy.

In July 2008, the decision was made to discontinue this study due to lower than expected enrolment, impairing the possibility to meet the primary objective with appropriate statistical power. However, the relatively large number of participants (n=121) randomized in the original PuLsE study offers the possibility to generate scientifically valuable and original findings if additional follow-up data can be gathered. After consultation with the PuLsE Investigators, Cyberonics decided to implement an observational long-term follow-up of the participants enrolled in the original PuLsE study.

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

加拿大
- - Halifax、加拿大
    - QE2 Health Sciences Centre Department of Neurology
  - Montreal、加拿大
    - Hopital Notre Dame
德国
- - Bonn、德国
    - Universitatskliniken Bonn
  - Erlangen、德国
    - Universitatsklinl Erlangen Zentrum fur Epilepsie
意大利
- - Ancona、意大利
    - Azienda Ospedaliero Universitaria
  - Bologna、意大利
    - Università di Bologna
  - Pisa、意大利
    - Universita di Pisa
  - Reggio Calabria、意大利
    - Azienda Ospedialiera "Bianchi Melacrino Morelli"
  - Rome、意大利
    - Unisersita Cattolica Del Sacro Cuore
  - Torino、意大利
    - Centro Epilessia
比利时
- - Brussels、比利时
    - ULB Hôpital Erasme
  - Gent、比利时
    - UZ Gent
法国
- - Grenoble、法国
    - Chu Grenoble
  - Lille Cedex、法国
    - Hopital Roger Salengro Service de Neurologie
  - Lyon、法国
    - Hopital Neurologique Unite d' epileptologie
  - Montpellier、法国
    - Hôpital Gui de Chauliac
英国
- - London、英国
    - The National Hospital for Neurology and Neurosurgery
荷兰
- - Oosterhout、荷兰
    - Hans Berger kliniek Neurology

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

16年及以上 (孩子、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

概率样本

研究人群

The study population will consist of participants previously enrolled in the original PuLsE study diagnosed with drug-resistant epilepsy with partial-onset seizures. All patients will be analyzed according to the treatment that they have actually received and followed in this new study regardless of what treatment groups they were randomized in the previous study.

描述

Inclusion Criteria:

To be eligible for the study, the participant must meet all the following criteria:

Participant must have been randomized in the original PuLsE study.
Participant must have baseline data from the original PuLsE study.
Participant is able to give accurate seizure counts, health outcomes information, and complete study instruments with minimal assistance.
Participant or legal guardian understands study procedures and has voluntarily signed an informed consent for PuLsE 2 in accordance with institutional and local regulatory policies.

Exclusion Criteria:

The presence of any of the following will exclude a participant from the study:

Participant has a history of non-compliance with the completion of a seizure diary.
Participant currently uses, or is expected to use during the study, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy.
Participant is expected to require full body magnetic resonance imaging during the clinical 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
VNS Therapy
Best Medical Practice

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
Exploratory evaluations 大体时间：5 years	The objective of this post-market study is to perform exploratory evaluations to identify clinically and statistically significant predictors of response at all follow-up visits in participants with drug-resistant epilepsy with partial-onset seizures treated with Best Medical Practice with or without adjunctive VNS Therapy. This will be accomplished through regression modeling of the response variates (including change in baseline quality of life score and percent reduction in seizure frequency).	5 years

次要结果测量

结果测量	大体时间
Change from baseline at all follow-up visits of Best Medical Practice with adjunctive VNS Therapy compared to Best Medical Practice 大体时间：5 years	5 years
Change from baseline at all follow-up visits across all health outcome measurements 大体时间：5 years	5 years
Evaluation of safety and tolerability 大体时间：5 Years	5 Years
Evaluation of change from baseline at all follow-up visits of Best Medical Practice with and without adjunctive VNS Therapy on health outcome measurements and quality of life (QOL) 大体时间：5 Years	5 Years
Sub-analysis to evaluate the change from baseline on quality of life 大体时间：5 Years	5 Years

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

Cyberonics, Inc.

调查人员

首席研究员：Philippe Ryvlin, MD、Unité d'épileptologie

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

2011年3月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2014年4月1日

研究注册日期

首次提交

2011年1月19日

首先提交符合 QC 标准的

2011年1月20日

首次发布 (估计)

2011年1月21日

研究记录更新

最后更新发布 (估计)

2014年10月16日

上次提交的符合 QC 标准的更新

2014年10月14日

最后验证

2014年10月1日