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临床试验/NCT06578416
NCT06578416招募中不适用

Developmental Trajectories to Stuttering Persistence and Recovery

Michigan State University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6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
招募中
入组人数
120
试验地点
2
主要终点
Stuttering Severity

研究概览

简要总结

The goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. During the study, children's speech and language abilities will be assessed with standardized assessments, and they complete several child-friendly experiments. During these experiments, brain activity will be recorded using specialized caps while children describe pictures, children will speak in two virtual-reality scenarios, and produce speech while keeping to a beat.

详细描述

The length of participation in our study depends on the subset of activities completed. Families in the longitudinal study will take part in three visits each lasting approximately 2 hrs for up to 5 years.

Parents and caregivers will complete parent questionnaires (1 x each year for up to 5 years) and a 5-minute, online survey in between visits to the lab (1x each year for up to 5 years). Children will take part in standardized and observational assessments (1x each year for up to 5 years). These may cover aspects of social/emotional development, cognition, and speech, language, and hearing abilities. These tests are used to assess whether a child falls within or outside of the normative range for his/her age.

Children will participate in one or more of the following tasks (1x each year for up to 5 years)

  • Listen to sounds or words and view or name pictures presented on a monitor. Brain activity electroencephalography (EEG) will be recorded while children listen to speech sounds and name pictures. This will be done with an elastic cap that holds special sensors (electrodes). Sensors will also be placed behind each ear, beside each eye, and under the left eye.
  • Virtual reality (VR). Children wear a VR headset and experience virtual, age-appropriate talking situations (e.g., answering questions in a classroom). While they talk in these scenarios, the headset measures where they are looking (eye tracking), and sensors on their forehead, hand, and finger measure their heart rate and sweat response.
  • Children will watch cartoons of animals jumping to a consistent beat (rhythm) and produce a word in time with the animal jumping/beat.
  • Children will repeat nonwords, name pictures, or count while wearing a cap with sensors. Half of the sensors emit light through while the other half measures the reflected light. These sensors give us information about brain activity and are not harmful.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • for controls:
  • English as first/primary language
  • No history of neurological disease
  • Normal or corrected visual acuity
  • No medications expected to affect performance
  • No intellectual impairment, autism spectrum disorder, ADHD
  • Age-appropriate scores on speech and language assessment battery
  • Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally
  • Inclusion Criteria for children who stutter:
  • English as first/primary language
  • No history of neurological disease
  • Normal or corrected visual acuity
  • No medications expected to affect performance
  • No intellectual impairment or ASD Scores on speech and language assessments indicating stuttering, phonological (speech sound), or language disorders
  • Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally

排除标准

  • 未提供

研究组 & 干预措施

Children who stutter

Preschool children who stutter aged 3 to 6-years

干预措施: Standardized assessments of speech and language abilities (Diagnostic Test)

Children who do not stutter

Preschool children who do not stutter aged 4 to 6-years

干预措施: Standardized assessments of speech and language abilities (Diagnostic Test)

结局指标

主要结局

Stuttering Severity

时间窗: 1 x each year for up to 5 years

Assess speech for the presence of stuttering disfluencies and calculate the severity of stuttering based on parent ratings and calculated as the percentage of disfluent syllables out of the total syllables of speech produced.

Virtual reality speaking scenarios

时间窗: 1 x each year for up to 5 years

Record looking events in msec during virtual reality scenarios (classroom of children and kitten)

EEG recording of event-related brain potentials

时间窗: 1 x each year for up to 5 years

Electroencephalographic (EEG) recordings of event-related brain potentials will be conducted during a picture identification task. ERPs will be averaged across conditions and reported in microvolts.

Speech production synchronization

时间窗: 1 x each year for up to 5 years

We record productions of a word spoken to the beat under different feedback conditions. We will assess timing measures reflecting the accuracy with which children synchronize their speech to the beat and retain the rhythm.

fNIRS recording of cortical hemodynamic responses

时间窗: 1 x each year for up to 5 years

Cerebral hemodynamic responses are recorded during the experiment with a continuous-wave fNIRS system (NIRx, Inc). The system uses LED light source optodes, and avalanche photodiode optode detectors for measuring intensity changes in the diffused light at a 10-Hz sampling rate. The optodes are embedded in a standard EEG cap. The concentrations of oxygenated hemoglobin and deoxygenated hemoglobin in micromols will be calculated across trial intervals as participants describe child-friendly picture scenes. These responses will then be averaged across trials for each child.

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

Bridget Walsh

Associate Professor of Communicative Sciences and Disorders

Michigan State University

研究点 (2)

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