Facilitation of Brain Plasticity for Language Recovery in Patients With Aphasia Due to Stroke
2018年3月13日 更新者：Nachum Soroker, MD
The purpose of this study is to investigate effects of tDCS stimulation in the left primary motor area followed by naming therapy to improve language functions in patients with aphasia in the sub-acute stage.
研究概览
详细说明
Transcranial Direct Current Stimulation (tDCS) is a simple and non-intrusive method that has demonstrated promising results in language rehabilitation of patients with aphasia.
Various studies have used different stimulation set-ups, some based on prior structural and functional brain mapping in order to choose the optimal stimulation region.
An additional approach that was found beneficial is stimulation of the left primary motor area (M1).
A major advantage of this approach is its relative simplicity that may increase the application of this intervention in clinical settings.
This intervention approach has been studied in patients with chronic aphasia and targeted on naming ability.
In the current study the investigators aim to study the influence of a stimulation set-up at M1 in stroke patients suffering from aphasia that are in the sub-acute stage.
In addition the investigators aim to study additional language functions including pragmatics and grammar.
The study will include 30 patients suffering from aphasia which are in the sub-acute stage.
The patients will undergo complete language assessments at 3 time points: baseline, post intervention (third week from recruitment) and one month follow-up.
The study group will include 15 patients that will undergo TDCS at the left M1 region followed by naming therapy.
The intervention will be given daily for duration of two weeks (5 days/week).
The control group will include 15 patients that will undergo the same protocol apart from sham TDCS.
The effect of the intervention will be examined taking into account the extent and location of the brain damage on language functions.
研究类型
介入性
注册 (预期的)
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。
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
25年 至 75年 (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:
- patients post stroke with right hemiplegia and aphasia with cognitive capacity to understand instructions and at the aphasia cut-of level defined by "SHEMESH" assessment
Exclusion Criteria:
- unstable clinical state, craniotomy, epilepsy, heart pacer or lack of cooperation
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental tDCS
TDCS stimulation at the left M1 region followed by naming therapy.
The intervention will be given daily for duration of two weeks (5 days/week).
|
The anode will be placed over the left M1 representation of the hand (C3 of the 10-20 EEG system).
Twenty minutes of anodal-tDCS (1mA) will be administered at the beginning of the daily treatment session.
Following the stimulation will be 45 minutes of naming therapy.
其他名称：
|
|
假比较器：sham tDCS
Sham tDCS at the left M1 region followed by naming therapy.
The intervention will be given daily for duration of two weeks (5 days/week).
|
The anode will be placed over the left M1 representation of the hand (C3 of the 10-20 EEG system). Twenty minutes of sham-tDCS will be administered at the beginning of the daily treatment session. During sham-tDCS, the current will be ramped up and remained at 1mA only for 30 s before ramping down, which does not affect neural functions, but assures effective blinding of participants due to the initial tingling sensation on the scalp. Following the sham stimulation will be 45 minutes of naming therapy. |
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 |
|---|---|---|
|
Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)
大体时间：baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
language test
|
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Western Aphasia Battery Hebrew
大体时间：baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
aphasia assessment
|
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
|
Change in Psycholinguistic Assessments of Language Processing in Aphasia
大体时间：baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
psycholinguistical assessment of aphasia
|
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
|
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：Nachum Soroker, M.D.、Loewenstein Hospital
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 (预期的)
2018年5月1日
初级完成 (预期的)
2019年12月30日
研究完成 (预期的)
2020年4月30日
研究注册日期
首次提交
2017年4月24日
首先提交符合 QC 标准的
2017年5月21日
首次发布 (实际的)
2017年5月23日
研究记录更新
最后更新发布 (实际的)
2018年3月14日
上次提交的符合 QC 标准的更新
2018年3月13日
最后验证
2018年3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.
experimental: tDCS的临床试验
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Universidad de AlmeriaSecretaría General de Universidades, Investigación y Tecnología, Junta de Andalucía, Spain邀请报名
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Northeastern UniversityMassachusetts General Hospital; National Institute on Aging (NIA)未知
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完全的