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临床试验/NCT04708197
NCT04708197已完成不适用

Role of rTMS in Recovery of Chronic Post Stroke Aphasia

Cairo University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
evaluate the recovery of post stroke aphasia by non invasive procedure without language therapy

研究概览

简要总结

high frequency excitatory rTMS applied over the dominant hemisphere in chronic post stroke aphasic patients to help the restoration of function by the left hemisphere

详细描述

Repetitive transcranial magnetic stimulation (rTMS) has been used in many studies as a novel intervention to treat disorders associated with stroke, including paralysis or dysphagia, hemispatial neglect, pain, and aphasia. Number of studies have demonstrated that low-frequency rTMS over the unaffected hemisphere can be useful for enhancing recovery in aphasic patients.. It is expected that application of high-frequency (facilitatory) rTMS over the dominant speech area would have a beneficial effect on improving speech performance.

The aim of this study is to evaluate the effect of excitatory high frequency rTMS on recovery of aphasia in chronic aphasic patients due to cerebrovascular stroke. Twenty patients with post-stroke aphasia were enrolled in this study. Patients were selected from those attending the stroke clinic of Neurology department, Cairo University during the period from June 2020 to November 2020. The protocol of the study was approved by the ethical committee of the Department of Neurology, Faculty of Medicine, Cairo University. The aim and procedures of the study were explained and written consent forms were taken from all patients prior to participation.

The eligibility criteria were: chronic post stroke nonfluent aphasia due to first-ever ischemic stroke in the distribution of middle cerebral artery diagnosed clinically and documented by computed tomography or magnetic resonance imaging on the brain, right handedness, both sexes, age ranged from 33 to 66 years old, duration at least 4 months from stroke onset, patients not receiving speech therapy and educated at least 10 years of education.

Exclusion criteria were: aphasia due to head injury or neurological disease other than stroke, other clinical forms of aphasia, unstable cardiac dysrhythmia or cardiac pacemaker, unstable or critically ill patients, current or history of epilepsy, skull wounds and pregnant females. Also patients with severe grade of weakness which interfere with writing ability.

The severity of aphasia was assessed for every patient using the Aphasia Severity Rating Scale (ASRS). According to this scale, language deficits were recognized ranging from 0 to 5 points.Every patient was then assessed for linguistic deficits using Kasr El-Eini Arabic Aphasia test (KAAT), which is a simple, rapid, standardized, valid, and reliable bedside test for Egyptian patients, literate and illiterate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
33 Years 至 66 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic post stroke nonfluent aphasia due to first-ever ischemic stroke in the distribution of middle cerebral artery diagnosed clinically and documented by computed tomography or magnetic resonance imaging on the brain
  • Right handedness
  • Both sexe groups
  • Age ranged from 33 to 66 years old,
  • Duration is at least 4 months from stroke onset,
  • patients never received speech therapy before
  • Educated for at least 10 years of education.

排除标准

  • Aphasia due to head injury or neurological disease other than stroke,
  • unstable cardiac dysrhythmia or cardiac pacemaker
  • unstable or critically ill patients
  • current or history of epilepsy, skull wounds and pregnant females.
  • patients with severe grade of weakness which interfere with writing ability.

结局指标

主要结局

evaluate the recovery of post stroke aphasia by non invasive procedure without language therapy

时间窗: 1 month to assess the recovery

rTMs is non invasive procedure may help improvement of speech performance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haidy Elshebawy

lecturer of Neurology ,MD ,faculty of medicine ,Cairo University

Cairo University

研究点 (2)

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