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临床试验/NCT02012374
NCT02012374已完成不适用

Overcoming Learned Non-Use in Chronic Aphasia: Behavioral, fMRI and QoL Outcomes

University of Massachusetts, Amherst2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年2月26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
24
试验地点
2
主要终点
• Change from baseline on Confrontation Naming Task

研究概览

简要总结

In this study the investigators are examining the effectiveness of intensive speech therapy in chronic moderate-to-severe stroke-induced aphasia under two conditions - responses "constrained" or unconstrained to speech. Both treatments involve massed practice communicating, using intensive language action therapy 3 hours/day, 5 days/week for two weeks, followed by six months of a home practice program. One treatment stresses spoken responses as the preferred expressive modality during intensive therapy. Before and after treatment, and following the home practice program and a period of no practice, the investigators will administer several tests and discourse samples to examine changes associated with the treatments. Participants will also undergo structural and functional MRI testing at these time points. The investigators will also attempt to quantify the degree to which improvements following intensive language therapy and home practice correlate with changes in Quality of Life measures as perceived by both participants with aphasia and their significant others. It is hypothesized that, whereas both treatments will lead to improvements in naming practiced words and communicating, outcomes will be enhanced for the group randomly assigned to the "constraint" condition. Moreover, performance will be enhanced on words practiced during the home practice program, including those that were not practiced during intensive therapy. Improved naming will correlate with modulation of 'signature' language and attentional networks, whose variability will depend on remaining viable brain structures. Initial severity and site/extent of lesion should predict patients' ability to transfer gains in naming to improvements in discourse.

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
Single (Participant)

入排标准

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

入选标准

  • unilateral left hemisphere stroke at least 6 months earlier
  • aphasia with moderate-to-severe word retrieval impairments
  • at least 21 years of age
  • premorbidly right handed
  • native speaker of English

排除标准

  • history of developmental learning difficulties
  • history of prior neurological illnesses
  • chronic medical illnesses that restrict participation in intensive therapy
  • recent alcohol or drug dependence
  • severe uncorrected impairments of vision or hearing
  • any contraindication to a 3T MRI procedure (e.g., claustrophobia, metal implants or fragments in body, pregnancy)

结局指标

主要结局

• Change from baseline on Confrontation Naming Task

时间窗: Change will be assessed immediately post-treatment (2 weeks)

次要结局

  • Change from baseline Boston Diagnostic Aphasia Examination(Change will be assessed immediately post-treatment (2 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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