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临床试验/NCT04575909
NCT04575909撤回不适用

Functional Connectivity and Predictors of Affective Aprosodia Intervention in Subacute Right Hemisphere Stroke

Johns Hopkins University2 个研究点 分布在 1 个国家开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in accuracy on affective prosody expression following aprosodia intervention compared to spontaneous recovery

研究概览

简要总结

This study is an investigation of a behavioral speech and language treatment for emotional prosody recognition and production deficits in subacute right hemisphere stroke.

详细描述

The phrase, "it's not what you say, but how you say it" neatly sums up prosody - the changes to one's tone of voice that transmit meaning. Changes to speech rate, rhythm, volume, and pitch to convey emotion fall into the category of affective, or emotional, prosody. That is, the changes made to the voice to express feelings, such as happy or sad.

Following damage to the right side of the brain, such as in stroke, difficulties in affective prosody understanding and use have been observed. These findings have led researchers to view the right hemisphere as playing a critical role for emotional prosody. Affective prosody difficulties do not always spontaneously improve after acute right hemisphere stroke, and only a few evidenced-based treatments are available for these individuals. It is also understood that affective prosody difficulties can negatively impact social interactions and relationships, including those who care for individuals with emotional prosody difficulties. With miscommunication frequently occurring between those living with affective prosody disorders and those with whom these people interact, the risk of reduced quality of life and social isolation is possible and could be related to poorer health outcomes. Not only might there be personal burdens associated with poor management of communication difficulties in right hemisphere stroke and dementia, but there might also be economic burdens as well. In addition to counseling caregivers, family, and friends about the communication changes of loved ones, more evidenced-based speech and language treatment options are needed for those living with affective prosody disorders.

Cognitive-Linguistic and Speech-Language Assessment: During baseline testing, detailed speech-language and cognitive-communication behavioral testing will occur, focusing on aprosodia, awareness, motor speech, attention, verbal working memory, executive function, discourse, social participation, and emotion. Detailed testing focusing on aprosodia will occur after each Intervention Phase.

Functional near-infrared spectroscopy: Resting state functional connectivity as measured via functional near-infrared spectroscopy (fNIRS) will be assessed at Baseline, Post Phase I, and Post Phase II testing time points to track longitudinal change in functional connectivity patterns associated with targeted aprosodia intervention.

Aprosodia Intervention Phase: The aprosodia intervention will target receptive and expressive prosody over the course of four (4) weeks (12 sessions total). The receptive prosody intervention phase will occur for two weeks (6 sessions total, 3 sessions/week), and the expressive prosody intervention phase will occur for two weeks (6 sessions total, 3 sessions/week). Within each phase, the types of cues participants receive will also vary. Half of the expressive prosody intervention phase will use explicit cues (3 sessions total, 1 week), and the other half of the expressive prosody intervention phase will use implicit cues (3 sessions total, 1 week). This same setup for expressive prosody intervention phase will be used in the receptive prosody intervention phase. In addition to these implicit and explicit cues, expressive prosody intervention will also include feedback to increase awareness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Key personnel will be blinded to participant testing timepoint by having separate personnel administer treatment and assessments for each participant.

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ischemic stroke to the right cerebral hemisphere
  • No history of other significant neurological disease or injury affecting the brain (excluding prior lacunar stroke, asymptomatic stroke, or TIA)
  • Proficient speaker of English prior to stroke per self-report
  • Capable of providing informed consent or indicating another to provide informed consent
  • Ages 18-89
  • Demonstration of receptive and/or expressive aprosodia on standardized measures of aprosodia
  • Does not have severe cognitive impairment (MoCA > 9)
  • Is not severely depressed (PHQ-9 < 20)
  • Does not have more than mild motor speech impairment (ASRS < 16 and Dysarthria severity < 3)
  • Normal or corrected-to-normal hearing and vision via screening tasks and self-report
  • Medically stable
  • Not taking any medications that may interfere with prosody processing
  • Participation in speech therapy not targeting aprosodia

排除标准

  • Ischemic stroke outside the right hemisphere or primary hemorrhagic stroke in the right hemisphere
  • History of symptomatic stroke or significant neurological disease or injury affecting the brain
  • No proficiency in English based on self-report
  • Unable to provide informed consent or to indicate another to provide informed consent
  • Children < 18 and adults 90+ years
  • No demonstration of expressive or receptive aprosodia
  • Severe cognitive-linguistic impairment (MoCA < 16)
  • Severe depression (PHQ-9 > 19)
  • More than mild motor speech impairment (ASRS > 15 + Dysarthria severity < 2)
  • Uncorrected hearing/vision loss via screening tasks and self-report
  • Not medically stable
  • Reported medication use that may interfere with prosody processing
  • Participating in outside speech therapy targeting aprosodia

结局指标

主要结局

Change in accuracy on affective prosody expression following aprosodia intervention compared to spontaneous recovery

时间窗: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention

Change in accuracy of participants' ability to express affective prosody on sentence lists (list score range 0-45), with increasing accuracy indicating better outcome.

Change in accuracy on standardized contextualized measures of affective prosody recognition

时间窗: 1 week after Phase I Intervention, 1 week after Phase II Intervention

Change in accuracy on The Awareness of Social Inference Test (score range 0-24, with increasing score indicating better outcome.

Behavioral and neurological predictors of aprosodia intervention outcomes

时间窗: Baseline, 1 week after Phase I or Phase II Intervention

Scores on baseline cognitive-linguistic assessments and percent damage to lesioned regions of interest, larger beta coefficients indicating a stronger relationship between predictor (baseline behavioral and neurological data) and predicted (prosody accuracy) variables.

Change in accuracy on affective prosody recognition following aprosodia intervention compared to spontaneous recovery

时间窗: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention

Change in accuracy of participants' ability to express affective prosody on sentence lists (list score range 0-45), with increasing accuracy indicating better outcome.

Change in accuracy on standardized contextual measures of affective prosody expression

时间窗: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention

Change in accuracy on the Montreal Evaluation of Communication (score range 0-18), with increasing score indicating better outcome.

Change in resting state functional connectivity

时间窗: Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention

Differences in resting state functional connectivity patterns within prosody-specific regions of interest and left homologues (connectivity association range 0-0.99), with increasing association values indicating stronger connectivity

次要结局

  • Change in standardized acoustic features (rate, frequency, intensity, rhythm), on standardized measures of prosody expression(Baseline, 1 week after Phase I Intervention, 1 week after Phase II Intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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