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临床试验/NCT04058184
NCT04058184已完成不适用

Prepulse Inhibition of the Startle Response in Youth Contact Sports Players

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Startle Probability

研究概览

简要总结

The study's main research question will be investigating whether or not there is a significant difference in Prepulse Inhibition (PPI) as well as startle response probability and magnitude between contact and noncontact youth sports players. The study team will test these questions using a controlled laboratory scenario in which the presentation of startle stimuli can be observed, measured, and quantified in order to compare the results between the two sample populations. During preliminary testing, the study team can predict that there will be no significant differences between contact sports players and noncontact sports players in their startle reactivity and level of exhibited PPI. Based on previous literature, the study team hypothesizes that those in the contact sports group will experience greater startle reactivity and less PPI than those in the noncontact sports group when they are tested at the end of their sports season. Using this information, the present study will allow for additional understanding of the neurological and physiological behaviors associated with subconcussive head impacts.

This study will assess and determine whether prepulse inhibition in youth contact sports players and non-contact sports players, both before and after a sports season, will significantly differ. Measures will include the startle magnitude, startle probability, reaction time, and accuracy of tone detection responses.

详细描述

Our main research question will be investigating whether or not there is a significant difference in PPI, as well as startle response probability and magnitude between contact and noncontact youth sports players. The study team will test these questions using a controlled laboratory scenario in which the presentation of startle stimuli can be observed, measured, and quantified in order to compare the results between the two sample populations. During preliminary testing, the study team can predict that there will be no significant differences between contact sports players and noncontact sports players in their startle reactivity and level of exhibited PPI. Based on previous literature, the study team hypothesizes that those in the contact sports group will experience greater startle reactivity and less PPI than those in the noncontact sports group when they are tested at the end of their sports season. Using this information, the present study will allow for additional understanding of the neurological and physiological behaviors associated with subconcussive head impacts.

This study will assess and determine whether prepulse inhibition in youth contact sports players and non-contact sports players, both before and after a sports season, will significantly differ. Measures will include the startle magnitude, startle probability, reaction time, and accuracy of tone detection responses.

The current study is a case-control study, examining the contact sports players as the testing sample and the noncontact sports players as the control sample.

  • Participants will arrive and hear an introduction of the study.

  • Participants (and their parent/guardian if under the age of 18) will read and sign an informed consent and/or informed assent form.

  • Participants will complete a series of questionnaires prior to electrode placement.

  • The Health History Questionnaire will be completed first to determine participant eligibility.

  • The STAI will be completed next to be used for further analysis in the data compilation.

  • Participants will have three electrodes placed on the skin.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants are specifically recruited for this study due to their involvement on a sports team that may or may not expose them to head impacts.

排除标准

  • Subjects on psychostimulant, antidepressant, or anxiolytic medications, as well as subjects who have experienced hearing loss, will not be eligible to participate.

结局指标

主要结局

Startle Probability

时间窗: startle test up to 1 hr from baseline

collected from each participant's raw EMG data

Startle Magnitute

时间窗: startle test up to 1 hr from baseline

collected from each participant's raw EMG data

Percentage of Prepulse Inhibition

时间窗: startle test up to 1 hr from baseline

collected from each participant's raw EMG data

次要结局

  • Reaction Time(startle test up to 1 hr from baseline)
  • Accuracy Measures(startle test up to 1 hr from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Prepulse Inhibition in Youth Contact Sports Players | 临床试验