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Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation (NTMSR)

2015年4月30日 更新者:Chervyakov Alexander、Russian Academy of Medical Sciences

Randomized Controlled Single-blind Research "Navigation Repetitive Transcranial Magnetic Stimulation in Stroke Rehabilitation"

The aim of research to study therapeutic possibilities of navigation transcranial magnetic stimulation in stroke rehabilitation, finding optimal protocol.

研究概览

地位

完全的

条件

详细说明

Stroke is the main cause of long-term disability among adults. Disability following stroke results in significant impairment of patients quality of life. There was a lot of investigations with using Transcranial Magnetic Stimulation (TMS) as effective additional therapy in stroke rehabilitation. In this researches uses different protocols and patient's categories: high-frequency, low-frequency, etc. Using method of navigation transcranial magnetic stimulation with neuroimaging could help in choosing optimal protocol, assess effectiveness of therapy and forming prognosis.

研究类型

介入性

注册 (预期的)

100

阶段

  • 第四阶段

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

      • Moscow、俄罗斯联邦、125367
        • Research center of neurology Russian academy of medical science
      • Moscow, Volokolamskoe shosse, 80、俄罗斯联邦、125367
        • Research center of neurology RAMS

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 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • a person with confirmed cerebral blood flow by ischemic from 8 days to 3 years in a pool of carotid arteries;
  • Persons with acute cerebrovascular accidents related to the severity of stroke scale NIHSS (National Institute of Health Stroke Scale) from 5 to 20 points;
  • People with cerebral circulatory assessment on the modified Rankin scale at most 3;
  • the availability of informed consent;
  • healthy volunteers who gave informed consent to participate in the study.

Exclusion Criteria:

  • The presence of an implanted pacemaker, intracardiac catheters, electronic pumps;
  • The plight of the patient, requiring the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats), including an increase of neurological symptoms after 8 days from the start of CVD, myocardial infarction, venous thrombosis of lower extremities, episodes of pulmonary embolism;
  • The severity of neurological deficit, which does not allow the patient to pass on their own 10 meters (you can use additional support);
  • Pregnancy or possibility of pregnancy in women of childbearing age (before menopause), according to a pregnancy test;
  • The presence of metallic elements or implants in the head region, located closer than 20 cm from the edge of the surface coil magnetic stimulator, with the exception of the mouth (metal brackets, vascular sutures, metal plates that cover the defects of the skull, metallic foreign body in the cranial cavity);
  • Identification of epileptiform activity during the screening of EEG before the study;
  • Epilepsy or seizures in history;
  • Patient refusal to participate in the study;

Exclusion criteria were:

  • Identified in the study of the general intolerance of the pulsed magnetic field;
  • The development of inclusion in the study after acute myocardial infarction and acute cerebral circulatory disorders;
  • Setting the pacemaker, intracardiac catheters, or operations on the brain, requiring the abandonment of metallic objects in the cranial cavity;
  • The onset of pregnancy;
  • Enhancement of the patient, requiring the maintenance of vital functions by hardware (mechanical ventilation);
  • The emergence of an epileptic seizure in response to the rhythmic TMS;
  • Patient refusal to continue participation 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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Low-frequency stimulation
Stimulation mode: 1 Hz, 100% MT, 20 minutes, unaffected hemisphere
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
其他名称:
  • Transcranial magnetic stimulation, brain stimulation
实验性的:High frequency stimulation
Stimulation mode: 10 Hz, 80% MT, 2 seconds - stimulation, 58 seconds - rest. - 8 session; affected hemisphere
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
其他名称:
  • Transcranial magnetic stimulation, brain stimulation
假比较器:Sham stimulation
Patients will receive standard treatment (kinesotherapy, physiotherapy) and simulate of transcranial magnetic stimulation. Also patients will not know about simulation (blind group)
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
其他名称:
  • Transcranial magnetic stimulation, brain stimulation
实验性的:Both hemispheric stimulation
Stimulation mode: low-frequency to unaffected hemisphere than high-frequency to affected.
Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
其他名称:
  • Transcranial magnetic stimulation, brain stimulation

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI
大体时间:up to 20 days
up to 20 days
The emergence of epileptic seizure
大体时间:up to 20 days
up to 20 days

次要结果测量

结果测量
措施说明
大体时间
Evaluation of the clinical condition of the patient
大体时间:up to 20 days
We plan to use different scales to examine clinical condition of patient: Fugl-Meyer scale, Ashworth scale, Perry scale, test with 10 meters walking, Bartel index, Renkin scale
up to 20 days

其他结果措施

结果测量
大体时间
Pregnancy
大体时间:up to 20 days
up to 20 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。

调查人员

  • 学习椅:Ludmila A. Chernikova、Research center of neurology Russian academy of medical science
  • 首席研究员:Michael A Piradov, professor、Research center of neurology RAMS

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。

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

2012年1月1日

初级完成 (实际的)

2014年11月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2012年6月28日

首先提交符合 QC 标准的

2012年7月27日

首次发布 (估计)

2012年7月30日

研究记录更新

最后更新发布 (估计)

2015年5月1日

上次提交的符合 QC 标准的更新

2015年4月30日

最后验证

2015年4月1日

更多信息

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.

Transcranial magnetic stimulation的临床试验

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