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临床试验/NCT02916524
NCT02916524Unknown不适用

Double-blind Randomized Trial Investigating the Use of Computational Modeling to Predict Rehabilitation Outcomes in Bilingual Aphasia

Boston University Charles River Campus6 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年4月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
6
主要终点
Word Retrieval Accuracy in both languages

研究概览

简要总结

The purpose of this investigation is to implement a computational model that can predict and optimize training and cross-language generalization patterns for bilingual persons with aphasia (BPA). The proposed work will determine the best possible treatment program for each individual patient even before they are rehabilitated. In addition, the computational model allows specification of variables such as age of acquisition, language exposure/proficiency, impairment and their systematic influence on a range of language rehabilitation outcomes.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any number of years of education
  • Bilingual: speaking both Spanish and English (or Chinese and English) with any degree of language proficiency prior to stroke
  • Aphasia secondary to a left-hemisphere stroke (diagnosed by a neurologist on the basis of clinical CT/MRI imaging or medical reports)
  • Aphasia resulting from stroke or dementia
  • Naming deficits must be present with concurrent lexical/semantic impairment
  • Visual and auditory acuity sufficient for all assessment and treatment procedures
  • Ability to understand study and follow study procedures for the entire length of the study

排除标准

  • Premorbid history of speech/language disorder
  • Proficient in more than just Spanish and English (or Chinese and English)
  • Overt, behaviorally noticeable, attentional limitations that interfere with completing the experimental tasks
  • Active medical disease that may compromise participation (e.g., cancer undergoing acute treatment, unstable diabetes, renal or hepatic insufficiency, fluctuating systemic immunological disease such as systemic lupus erythematosis, etc.)
  • Currently taking medications that are known to exert significant effects on cognitive processes, such as neuroleptics, steroids, anticholinesterase inhibitors, etc.
  • Current drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the principal investigator
  • Inability or unwillingness of individual to give written informed consent
  • Diagnosed with mental illness other than active depression
  • Neurological condition other than that which resulted in aphasia

结局指标

主要结局

Word Retrieval Accuracy in both languages

时间窗: Through study completion, an average of 10 weeks

Accuracy of naming of pictured treated and untreated items in both languages will be assessed in probes conducted separate from treatment. Probes were conducted repeatedly throughout the study, from baseline (prior to treatment) to the end of treatment. All naming responses were scored using as correct or incorrect. A percentage accuracy was calculated for each set of items for every probe session. Baseline probe scores were compared to end of treatment probe scores to obtain individual effect sizes for each sets of items for each participant (i.e., several effect sizes were calculated for each participant).

次要结局

  • Verbal fluency task (COWAT) in both languages(Week 1 and up to 10 weeks)
  • Psycholinguistic assessments of language processing in aphasia (PALPA) in both languages(Week 1 and up to 10 weeks)
  • Bilingual Aphasia Test (BAT) B and C in both languages(Week 1 and up to 10 weeks)
  • Boston Naming Test (BNT) in both languages(Week 1 and up to 10 weeks)
  • Western Aphasia Battery (WAB) in both languages(Week 1 and up to 10 weeks)
  • Pyramids and Palm Trees Test (PAPT) 3 pictures version(Week 1 and up to 10 weeks)
  • Cognitive Linguistic Quick Test (CLQT) in both languages(Week 1 and up to 10 weeks)
  • Category fluency task in both languages(Week 1 and up to 10 weeks)
  • Aphasia Bank(Week 1 and up to 10 weeks)
  • Communication Effectiveness Index (CETI) for both languages(Week 1 and up to 10 weeks)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Swathi Kiran

Professor

Boston University Charles River Campus

研究点 (6)

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