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临床试验/NCT05286151
NCT05286151招募中不适用

Subcortical Network Connectivity and Temporal Processing in Children With Persistent and Recovered Stuttering

University of Michigan2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年7月23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
500
试验地点
2
主要终点
Rhythm discrimination (d')

研究概览

简要总结

The specific purpose of this clinical trial is to compare performance on rhythm perception and production tasks between children who stutter and children who do not stutter. The overall project also aims to investigate how performance on rhythm tasks may be related to brain activity (non-clinical trial).

详细描述

Participants in the clinical trial portion of this study will complete rhythm discrimination and finger tapping experiments once a year for 3 years. The study team will compare performance between groups. Participants will also participate in the non-trial portion of the project that includes having magnetic resonance imaging (MRI) each year for 3 years.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
9 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children who stutter:
  • •English as primary language
  • •Current or past stuttering diagnosis
  • •Inclusion Criteria Children who do not stutter:
  • •English as primary language

排除标准

  • •Children who stutter:
  • •Diagnosed/under treatment for any neurological or psychiatric conditions
  • •Head trauma with loss of consciousness
  • •Major medical illness
  • •Hearing loss- Language/motor delay (below -2 standard deviations on standardized assessments)
  • •Face, motor, or reflex abnormalities
  • •Exclusion Criteria Children who do not stutter:
  • •Personal or family history of stuttering
  • •Diagnosed/under treatment for any neurological or psychiatric conditions
  • •Head trauma with loss of consciousness
  • •Major medical illness
  • •Hearing loss
  • •Language/motor delay (below -2 standard deviations on standardized assessments
  • •Face, motor, or reflex abnormalities

研究组 & 干预措施

Children who stutter

Experimental

Children who stutter

干预措施: Rhythm discrimination (Behavioral)

Children who do not stutter

Experimental

Children who do not stutter

干预措施: Rhythm discrimination (Behavioral)

结局指标

主要结局

Rhythm discrimination (d')

时间窗: Year 3

Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different. Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR)).

Rhythm discrimination (d')

时间窗: Year 1

Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different. Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR)).

Rhythm discrimination (d')

时间窗: Year 2

Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different. Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR)).

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

Soo-Eun Chang

Associate Professor of Psychiatry

University of Michigan

研究点 (2)

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