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临床试验/NCT03164213
NCT03164213Unknown不适用

Facilitation of Brain Plasticity for Language Recovery in Patients With Aphasia Due to Stroke

Nachum Soroker, MD0 个研究点目标入组 30 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • unstable clinical state, craniotomy, epilepsy, heart pacer or lack of cooperation

研究组 & 干预措施

Experimental tDCS

Experimental

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).

干预措施: experimental: tDCS (Device)

sham tDCS

Sham Comparator

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).

干预措施: sham tDCS (Device)

结局指标

主要结局

Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)

时间窗: baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.

language test

次要结局

  • Change in Western Aphasia Battery Hebrew(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(baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.)

研究者

发起方
Nachum Soroker, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nachum Soroker, MD

Head, Department of neurologic rehabilitation, Loewenstein

Loewenstein Hospital

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