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临床试验/NCT02622945
NCT02622945撤回不适用

Transcranial Direct Current Stimulation in Acute and Chronic Post-stroke Aphasia

Johns Hopkins University1 个研究点 分布在 1 个国家开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in picture naming scores in trained and untrained items

研究概览

简要总结

This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.

详细描述

This study aims to determine whether behavioral word-retrieval therapy coupled with anodal tDCS will improve the fluency and name retrieval performance of participants with post-stroke aphasia more efficiently and for greater duration than language therapy alone (i.e. in the sham condition).

tDCS neuronal targets will be selected in this order:

  1. left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension),
  2. left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or
  3. right cerebellum (important for learning, and consistently activated in naming task) if both of the other areas are infarcted.

The same areas will be stimulated during the first tDCS and sham periods. If the participant returns for a second period of tDCS and sham with language therapy, the right cerebellum will be stimulated (if it was the only uninfarcted target area investigators will stimulate this area again). For cerebellar stimulation, either anodal or cathodal will be used as studies show that anodal or cathodal stimulation has an effect on cognitive functions.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits
  • •Premorbid speakers of English
  • •Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment
  • •Stroke size: any l
  • •Location: Left hemisphere strokes only from any etiology.
  • •Time since stroke onset: 1 day to 20 years.

排除标准

  • •uncorrected visual or hearing impairment by self report
  • •other premorbid neurological disorder affecting the brain
  • •any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia
  • •premorbidly diagnosed with a developmental language disorder
  • •Pregnant women will also be excluded

研究组 & 干预措施

Active tDCS plus Speech-Language Therapy

Experimental

Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.

干预措施: Active tDCS plus Speech-Language Therapy (Device)

Sham plus Speech-Language Therapy

Sham Comparator

Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.

干预措施: Sham plus Speech-Language Therapy (Device)

结局指标

主要结局

Change in picture naming scores in trained and untrained items

时间窗: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups

次要结局

  • Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set(Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups)
  • Change in Written naming of objects and actions(Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups)
  • Change in working memory (digit span)(Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups)
  • Change in verbal fluency(Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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