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临床试验/NCT03486782
NCT03486782已完成不适用

Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Language and Cognitive Function in Stroke Patients

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Changes in Korean Western Aphasia Battery

研究概览

简要总结

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of language and cognitive function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on ipsilesional inferior frontal cortex, ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex. 2) Single stimulation 1: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional inferior frontal cortex; 3) Single stimulation 2: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional supraorbital area.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •left hemisphere involved stroke patients
  • •patients diagnoses as post stroke aphasia

排除标准

  • •history of psychiatric disease
  • •patients with metal implants
  • •history of epilepsy
  • •pregnancy
  • •skin defect at the site of electrode attachment

研究组 & 干预措施

Dual stimulation

Active Comparator

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex and cathodal stimulation of contralesional supraorbital area

干预措施: IFG stimulation (Device)

Dual stimulation

Active Comparator

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex and cathodal stimulation of contralesional supraorbital area

干预措施: DLPFC stimulation (Device)

Dual stimulation

Active Comparator

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex and cathodal stimulation of contralesional supraorbital area

干预措施: aphasia therapy (Behavioral)

Single stimulation 1

Active Comparator

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex

干预措施: IFG stimulation (Device)

Single stimulation 1

Active Comparator

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex

干预措施: aphasia therapy (Behavioral)

Single stimulation 2

Active Comparator

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area

干预措施: IFG stimulation (Device)

Single stimulation 2

Active Comparator

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area

干预措施: aphasia therapy (Behavioral)

结局指标

主要结局

Changes in Korean Western Aphasia Battery

时间窗: Baseline and after intervention (approximately 2 weeks)

assessment of language function and provide aphasia quotients

Changes in Korean Boston naming test

时间窗: Baseline and after intervention (approximately 2 weeks)

measures naming ability thorough picture naming test

次要结局

  • Digit span test(Baseline and after intervention (approximately 2 weeks))
  • Changes in brain activation of resting-state and task functional MRI(Baseline and after intervention (approximately 2 weeks))
  • Changes of Cortical activation(Baseline and after intervention (approximately 2 weeks))
  • Korean Color Word Stroop test(Baseline and after intervention (approximately 2 weeks))
  • Korea Montreal Cognitive Assessment(Baseline and after intervention (approximately 2 weeks))
  • Controlled Oral Word Association Test(Baseline and after intervention (approximately 2 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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