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临床试验/NCT01221779
NCT01221779Unknown2 期

Chronic Aphasia - Improved by Intensive Training and Electrical Brain

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
2 期
入组人数
40
试验地点
1
主要终点
Boston Naming Test

研究概览

简要总结

The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the out of intensive language therapy in chronic aphasia

详细描述

Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms.

Thus, in the present project we aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. We will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. We will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • right-handedness
  • single first time left-hemisphere stroke
  • fluent- or non-fluent chronic aphasia (more than six months post-stroke)
  • anomia (PR>10 and PR<60 Aachen Aphasia Naming Subtest)
  • native German Speaker

排除标准

  • more than one stroke
  • alcoholism, severe psychiatric conditions, other neurological conditions
  • other non-treated medical problems, severe microangiopathy
  • pregnancy

结局指标

主要结局

Boston Naming Test

时间窗: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)

次要结局

  • Boston Naming Test(Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up))
  • Naming performance during functional magnetic resonance scanning(Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing))
  • Naming performance during functional magnetic resonance imaging(Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up))

研究者

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

Marcus Meinzer

Creutzfeldt Fellow

Charite University, Berlin, Germany

研究点 (1)

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