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3010 Effects of non-invasive brain stimulation on speech fluency and brain activity in adults who stutter: a randomized controlled clinical trial

机译:3010非侵入性脑刺激对口吃成人口语流利度和脑活动的影响:一项随机对照临床试验

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摘要

OBJECTIVES/SPECIFIC AIMS: The goal of this study is to measure speech fluency and brain activity before and after 5 days of behavioral speech fluency training alone (sham group) or speech training plus stimulation (active group). A 1-month follow up will also be completed. The first primary outcome measure is changes in brain activation in speech motor control/timing network. The second primary outcome measure is changes in percentage of stuttered syllables during speech sample (speech fluency). The secondary outcome measure is changes from baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES), a detailed subject rating of how stuttering affects their lives. METHODS/STUDY POPULATION: This study is a between subjects, counterbalanced, sham-controlled, double-blind design. Participants will be 40 adults who stutter who will be randomized (using minimization) into either the active or sham stimulation group, with all other study procedures being the same in both groups. Participants will completed 2 days of baseline testing, 5 consecutive days of brain stimulation during speech training, 2 days of post-testing, and a 1-month follow up. All outcome measures will be completed immediately before and after the 5 days of brain stimulation, as well as at follow-up. as of submission, 10 subjects have completed the study. Data collection is ongoing. RESULTS/ANTICIPATED RESULTS: Expected results. Questions this study aims to answer: 1) Does a more intensive training period lead to decreased stuttering? We expect that both groups will show improvements in speech fluency immediately after training. We expect that those in the active group will continue to exhibit improved speech fluency at 1 month follow up. 2) Does a more intensive training period lead to changes in brain activity? We expect that both groups will exhibit increased activity in auditory/motor regions immediately after training. We expect that the active group will continue to exhibit an increase in activity in these regions at 1 month follow up. DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first RCT study involving brain stimulation in adults who stutter. We expect to provide preliminary evidence for the effectiveness of tDCS as an augmentative agent for increased speech fluency in adults who stutter during a brief, intensive training paradigm. We also expect to be able to provide information on the effects of tDCS on brain activity in speech and auditory-motor regions of the brain. The findings will add to the growing body of literature suggesting that developmental stuttering is a neurodevelopmental disorder with roots in timing and rhythmic aspects of speech motor control and auditory-motor integration.
机译:目的/特定目的:这项研究的目的是在仅进行行为言语流畅训练(假组)或言语训练加刺激(活动组)的5天之前和之后测量言语流畅度和大脑活动。为期1个月的随访也将完成。第一个主要结果指标是语音运动控制/定时网络中大脑激活的变化。第二个主要结果指标是语音样本中口吃音节的百分比变化(语音流利度)。次要结果衡量标准是对演讲者口吃经验总体评估(OASES)中基线的变化,即口吃如何影响其生活的详细主题评分。方法/研究人群:本研究是受试者之间,平衡的,假手术控制的,双盲设计。参与者将是40名口吃的成年人,他们将被随机分配(使用最小限度)到活动刺激或假刺激组中,其他所有研究程序在两组中均相同。参与者将完成为期2天的基线测试,语音训练期间连续5天的脑刺激,测试后2天以及1个月的随访。在5天的大脑刺激前后,以及随访时将立即完成所有结果指标。截至提交,已有10名受试者完成了研究。数据收集正在进行中。结果/预期结果:预期结果。该研究旨在回答以下问题:1)强化训练时间是否会减少口吃?我们希望这两个小组在接受培训后都能立即提高语音流畅度。我们希望,在接下来的1个月的随访中,活跃人群的言语流畅性将继续提高。 2)强化训练时间是否会导致大脑活动的改变?我们希望两组在训练后立即在听觉/运动区域表现出增强的活动。我们希望在接下来的1个月中,活跃的小组在这些地区的活动将继续增加。讨论/意义:这是第一个涉及成人口吃脑刺激的RCT研究。我们希望提供简要的证据,证明tDCS作为在短期,密集的训练范式中口吃的成年人中增强口语流利性的增强剂的有效性。我们还希望能够提供有关tDCS对大脑言语和听觉运动区域大脑活动的影响的信息。这些发现将增加越来越多的文献,表明发育停滞是一种神经发育障碍,其根源在于言语运动控制和听觉运动整合的时间和节奏方面。

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