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Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

2013年9月9日 更新者：Di Lazzaro Vincenzo、Campus Bio-Medico University

An Open Label, One Arm, Dose Escalation Study to Evaluate the Safety of Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke.

There is great interest in the development of novel therapies for acute ischemic stroke because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for acute ischemic stroke therapy because of their effects on the main mechanisms of brain ischemic damage and regeneration.The main purpose of this open label, one arm, dose escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective tool to promote recovery in acute ischemic stroke patients Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be evaluated by the incidence of adverse events and mortality throughout the stimulation period and the 1-year follow-up. Secondary outcomes will consist in change from baseline in clinical and radiological scores.

研究概览

地位

未知

条件

干预/治疗

研究类型

介入性

注册 (预期的)

9

阶段

  • 不适用

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

  • 意大利
      • Rome、意大利、00128
        • 招聘中
        • Institute of Neurology, Campus Biomedico University
        • 接触：
        • 首席研究员：
          • Fioravante Capone, MD
        • 副研究员：
          • Marzia Corbetto, MD

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

描述

Inclusion Criteria:

  • males or females, aged over 18
  • evidence of mono-hemispheric ischemic stroke confirmed by brain MRI
  • first onset stroke patients
  • onset of symptoms within 48 hours prior to enrollment
  • National Institutes of Health Stroke Scale (NIHSS) score greater than 4
  • patient is alert, medically stable according to the treating physician and able to follow simple verbal commands
  • signed written informed consent prior to entry into the study

Exclusion Criteria:

  • acute intracranial hemorrhage confirmed by brain CT or MRI scan
  • previous ischemic or hemorrhagic stroke
  • seizure at the onset of stroke or a history of epilepsy
  • contraindications to transcranial magnetic stimulation: implanted metallic parts of implanted electronic devices, including pacemakers,defibrillators, implanted medication pump, or implanted brain stimulator
  • aneurysm clip or other metal in body
  • life expectancy less than 3 months
  • other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction, or complex disease that may confound treatment assessment
  • women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
  • any condition that would prevent the subject from giving voluntary informed consent
  • current participation in another study with an investigational drug or device

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

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Pulsed ELF-MF
Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF at increasing daily exposure (45, 120, 240 min).
设备：pulsed ELF-MF
(75 Hz, 1,8 mT)

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
Incidence of adverse events
大体时间：1 year
The primary outcome will be evaluated by the incidence of adverse events (AEs), severe AEs (SAEs) and mortality throughout the stimulation period and the 1-year follow-up.
1 year

次要结果测量

结果测量
措施说明
大体时间
Change in National Institutes of Health Stroke Scale (NIHSS) score
大体时间：Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
NIHSS is a validated scale from 1-42 to evaluate stroke severity
Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Change in Modified Rankin Scale (mRS) score
大体时间：Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
mRS is a straightforward evaluation of the functional limitations from stroke
Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Change in Barthel Index (BI)
大体时间：Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
BI is a reliable disability profile scale from 0 to 15 to evaluate a patient's self-care abilities in 10 areas, including bowel and bladder control
Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment
Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI
大体时间：Baseline; 30 days.
ΔILV is defined as ILV measured by FLAIR sequence at 30 days after pulsed ELF-MF treatment minus the initial ILV measured by diffusion-weighted imaging (DWI) trace sequence before pulsed ELF-MF treatment.
Baseline; 30 days.

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

Campus Bio-Medico University

调查人员

  • 首席研究员：Vincenzo Di Lazzaro, MD、Institute of Neurology, Campus Biomedico University of Rome

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

2013年8月1日

初级完成 (预期的)

2014年9月1日

研究注册日期

首次提交

2013年9月9日

首先提交符合 QC 标准的

2013年9月9日

首次发布 (估计)

2013年9月13日

研究记录更新

最后更新发布 (估计)

2013年9月13日

上次提交的符合 QC 标准的更新

2013年9月9日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ELF-01

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

pulsed ELF-MF的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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