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临床试验/NCT02046941
NCT02046941已完成不适用

Brain Biomarkers of Response to Treatment for Apraxia of Speech

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Change From Baseline in Percent of Trained Items Correctly Repeated

研究概览

简要总结

The study will use MRI brain imaging to identify brain changes associated in stroke patients after they receive speech-language treatment for their speech difficulties.

详细描述

The goals of the current study are to identify grey and white matter regions that are predictive of speech treatment response and measure neural plasticity in response to speech treatment, using state-of-the-art neuroimaging and statistical processing techniques in a group of well-characterized left hemisphere patients meeting strict inclusionary criteria. Specifically, the investigators will use voxel-based lesion symptom mapping to identify lesion sites most predictive of a positive response to speech treatment and advanced diffusion imaging techniques to map changes in the integrity of white matter tracts from pre- to post-treatment.

研究设计

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

入排标准

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

入选标准

  • Inclusion criteria are age 40-90
  • primary English speaker since < age 5
  • a history of a single left hemisphere stroke
  • at least 1 year post-stroke
  • at least 12 years of education
  • pre-morbidly right-handed (Edinburgh Handedness Questionnaire)
  • within normal limits on the Test of Non-Verbal Intelligence

排除标准

  • Exclusion criteria will include a pre-morbid neurologic or psychiatric history
  • history/current substance abuse disorder
  • MRI contraindications
  • other motor speech disorders (e.g., dysarthria)
  • current or recent (<2 months) speech/language therapy
  • prior SPT
  • pre-morbid history of speech/language disorders
  • significant hearing disabilities (based on a pure-tone audiological screen at 35 dB HL at 500, 1K, and 2K Hz for at least one ear)
  • aphasia severity resulting in <30th percentile performance on the Porch Index of Communicative Ability-R

研究组 & 干预措施

Speech Production Treatment

Experimental

This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction. The investigators chose this treatment for the following reasons: 1) rigor of development demonstrated across multiple studies, 2) large and predictable effects with published, quantified effect sizes, 3) a demonstrated pattern of generalization to untrained items, illustrating experimental control, 4) an established multi-modal stimulation protocol, and 5) use of repeated practice, which is associated with neural plasticity.

干预措施: Speech Production Treatment (Behavioral)

结局指标

主要结局

Change From Baseline in Percent of Trained Items Correctly Repeated

时间窗: 8 weeks

For each participant, three target sounds were chosen: single consonants, vowels, or clusters at the word level. Based on these target sounds, 10 word items were generated for each target sound that served as Trained Items. Participants were tested on lists of Trained Items (probe trials) during repeated sessions in pre-intervention stage to establish baseline performance (percent of each word list repeated correctly) and during every other treatment session (again, percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to the end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the Busk \& Serlin (1992) d2 statistic, which involves subtracting the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation of the two phases. The larger the d2 effect size, the larger the effect of the treatment.

Change From Baseline in Percent of Untrained Items Correctly Repeated

时间窗: 8 weeks

To test generalization, we assessed the change in performance (percent correct repetition) on lists of 10 Untrained Items that had the same speech production targets as each patient's lists of 10 Trained Items, balanced for syllabic structure, word frequency, grammatical form class, and stress pattern. Just as for Trained Items, participants were tested on the lists of Untrained Items (probe trials) during repeated sessions in the pre-intervention stage to establish baseline performance and during every other treatment session (percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the d2 statistic: the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation. The larger the d2 effect size, the larger the effect of the treatment.

次要结局

  • Percentage Change in Fractional Anisotropy (FA)(8 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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