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临床试验/NCT01924702
NCT01924702Unknown2 期

Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)

Charité Neurocure AG Flöel1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
24
试验地点
1
主要终点
naming performance

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 outcome 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 the investigators aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. They 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. The Investigators 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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic stroke (> 1 year after event)
  • aphasia due to stroke with naming impairment
  • German as first language
  • first-ever stroke

排除标准

  • more than 1 stroke
  • history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity
  • contraindications for Magnetic Resonance Imaging or transcranial direct current stimulation

结局指标

主要结局

naming performance

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

  • 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))
  • Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)(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(Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up))

研究者

发起方
Charité Neurocure AG Flöel
申办方类型
Other
责任方
Sponsor

研究点 (1)

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