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临床试验/NCT03550092
NCT03550092已完成不适用

Application of Graph Theory to Both Resting-state and Task-based fMRI Data to Uncover Brain-behavior Relationships Related to Therapy Outcomes in Aphasia

Penn State University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年9月25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
23
试验地点
2
主要终点
Therapy Effect Size: Change in word generation performance from pre- to post-treatment measured using a version of Cohen's d

研究概览

简要总结

Aphasia is a loss of language due to stroke or other brain injury. Word-finding in conversation is a universal and persistent difficulty in aphasia. While several techniques exist to improve word-finding in aphasia, it is unclear how the brain changes in response to behavioral therapy. In this study, persons with aphasia will receive behavioral therapy aimed at helping them to be more successful at finding words. Twenty therapy sessions will be provided in a 10-week period. Each therapy session will last about 2 hours and will include a variety of language tasks. Prior to beginning word-finding therapy, each participant will receive two fMRI scans, spaced 10 weeks apart. After finishing therapy, each participant will receive two additional fMRI scans, spaced 10 weeks apart. For a portion of the MRI scan, participants will complete language tasks. The purpose of these fMRI scans is to measure brain changes that may occur due to successful behavioral therapy. The hypotheses are as follows: First, that the behavioral therapy will improve word-finding as it has been shown to do in the past. Second, that the brain will change in a couple of different ways. It is expected that the network of regions that support word-finding will be more connected and work together more efficiently after therapy. It is also expected that the networks of regions that support other aspects of cognitive function, such as attention and executive function, will also be more connected and work together more efficiently.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of aphasia
  • Sustained stroke more than 6 months prior to consent
  • Right-handed
  • Native speakers of English
  • Completed at least a high school education
  • Normal or corrected-to-normal vision and hearing
  • Provide written informed consent
  • Participants will be medically stable and at least wheelchair ambulatory at the time of participation with uncompromised use of the left hand

排除标准

  • History of degenerative neurological disorders (e.g., Alzheimer's disease), acquired neurological disorders other than aphasia from stroke (e.g., traumatic brain injury), developmental neurological disorders (e.g., autism), or psychiatric disorders
  • An active medical condition that could compromise participation (e.g., cancer undergoing acute treatment)
  • Not safe to enter the bore of the magnet (e.g., pacemaker)
  • Taking medications that are known to exert significant effects on cognitive processes
  • Pregnancy or possibility of pregnancy
  • Do not meet the above inclusionary criteria

结局指标

主要结局

Therapy Effect Size: Change in word generation performance from pre- to post-treatment measured using a version of Cohen's d

时间窗: At baseline and at approximately 10 weeks (i.e., the end of therapy)

The mean of the baseline scores is subtracted from the mean of the post-treatment scores, and then divided by the standard deviation (SD) of the baseline scores. 6.5-8 is considered a small effect size, 8-9.5 is medium, and above 9.5 is large.

Change in fMRI activation patters from pre- to post-treatment

时间窗: At baseline and at approximately 10 weeks (i.e., the end of therapy)

Blood-oxygen-level-dependent MRI signal measured during task and rest and subjected to statistical tests of significant change from pre- to post-treatment.

次要结局

未报告次要终点

研究者

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

Chaleece Sandberg

Assistant Professor

Penn State University

研究点 (2)

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