此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke (NEUROSTIM)

2018年9月25日 更新者:Hospital Israelita Albert Einstein

Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.

This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).

研究概览

详细说明

The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.

Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.

研究类型

介入性

注册 (实际的)

30

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

      • Sao Paulo、巴西、05652-901
        • Danielle Boasquevisque

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
  • Unilateral paresis of upper limb
  • National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
  • Ability to provide written informed consent (patient ou legal representative).

Exclusion Criteria:

  • Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
  • Neurologic diseases except migraine.
  • Modified Rankin Scale > 2 prior to stroke.
  • Advanced systemic disease such as cancer or advanced chronic renal disease.
  • Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
  • Contraindication for physical therapy.
  • Pregnancy.
  • Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
  • Comprehension aphasia
  • Dementia
  • Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem

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:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器:Active tDCS+ Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)
Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 60 minutes
假比较器:Sham tDCS+Physical Therapy

Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes.

Number of treatment sessions: 6 (3 times a week, for 2 weeks)

In sham tDCS, no current will be delivered through the tDCS device.
Physical therapy will be administered for 60 minutes

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
Safety of the intervention as assessed by frequency of adverse events
大体时间:2 weeks
frequency of adverse events in the active and sham arms
2 weeks

次要结果测量

结果测量
措施说明
大体时间
Improvement post treatment as measured by the Modified Rankin Scale
大体时间:2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Improvement post treatment as measured by the NIH Stroke Scale
大体时间:2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Improvement post treatment as measured by the Stroke Impact Scale
大体时间:2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
大体时间:2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Improvement post treatment as measured by the Modified Ashworth Scale
大体时间:2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Improvement post treatment as measured by the Motor Activity Log
大体时间:2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Montreal Cognitive Assessment Test
大体时间:2 weeks and 14 weeks
No cognitive deterioration post treatment
2 weeks and 14 weeks
Structural Connectivity as measured by diffusion tensor imaging analysis
大体时间:2 weeks
Improvement post treatment
2 weeks
Functional Connectivity as measured by resting-state functional magnetic imaging analysis
大体时间:2 weeks
Improvement post treatment
2 weeks
Improvement post treatment as measured by the Barthel index
大体时间:2 week and 14 weeks
Improvement post treatment
2 week and 14 weeks
Safety of the intervention as assessed by frequency of adverse events
大体时间:14 weeks
frequency of adverse events in the active and sham arms
14 weeks
Improvement post treatment as measured by Pittsburgh Sleep Quality Index
大体时间:2 week and 14 weeks
Improvement post treatment
2 week and 14 weeks

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:Adriana B Conforto, MD Phd、Hospital Israelita Albert Einstein

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

2015年5月1日

初级完成 (实际的)

2018年3月31日

研究完成 (实际的)

2018年3月31日

研究注册日期

首次提交

2015年4月24日

首先提交符合 QC 标准的

2015年5月22日

首次发布 (估计)

2015年5月27日

研究记录更新

最后更新发布 (实际的)

2018年9月27日

上次提交的符合 QC 标准的更新

2018年9月25日

最后验证

2018年9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)?

IPD 计划说明

Deidentified imaging data will be shared with collaborators

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.

订阅