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临床试验/NCT04041960
NCT04041960已完成不适用

Examining the Effects of Theta Burst Stimulation on the Neural Network Associated With Reading in Adult Struggling Readers

Georgia State University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年5月1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
28
试验地点
2
主要终点
Change in lexical decision making

研究概览

简要总结

The purpose of this project is to understand how reading is related to brain function. To do this, participants will perform some reading tasks and then have magnetic resonance imaging (MRI) brain scans. Participants will then receive transcranial magnetic stimulation (TMS) to the reading areas of the brain, followed by a second MRI brain scan. This will temporarily activate reading abilities. We want to better understand how the reading system in the brain functions.

详细描述

Subjects will come in for up to 2 sessions, each lasting between 1 - 4 hours. Subjects will complete reading and cognitive tasks associated with reading, and receive TMS as well as 2 MRI brain scans, in order to assess brain regions important to reading.

Initial, basic screening including MRI and TMS safety screening will be conducted over the phone during the recruitment phone call and/or screening forms will be emailed to prospective subjects for their review. Those individuals that qualify will be scheduled for session 1. Session 1 will take between 1 and 3 hours. Subjects who pass health/MRI/TMS screening will complete cognitive/reading screening measures as well as the demographic information survey. They will also be trained on the MRI and TMS procedures. If all screening criteria is met, subjects will be asked to return for a second session which will include the MRI and TMS portions of the study.

Session 2 will take place on a separate day and consist of renewal of the health/MRI/TMS screening forms prior to the MRI scan or TMS administration. The baseline MRI portion of the session will last approximately 1.5 hours including screening, training, and scan time. The MRI scan will be followed by the TMS portion which will last approximately 45 minutes. The post-TMS MRI will take place immediately following the TMS session and will last approximately 45 minutes. Reading assessments will be administered before the baseline MRI and again after TMS stimulation/before post-TMS MRI, each lasting approximately 10 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Must meet the study reading criteria based on their reading and reading-related screening test results
  • native speakers of English
  • Right handed
  • minimum of low average intellectual functioning (SS>=80) on at least one subscale on the Wechsler Abbreviated Scale of Intelligence-2

排除标准

  • hearing deficits (>25dB at 500+ Hz), visual deficits (>20/40), serious emotional problems, certain neurological conditions (e.g., uncontrolled seizure disorders)
  • Braces on teeth, a cardiac pacemaker; hearing aid; other metal in their body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects
  • TMS or MRI Screening and Contraindication Forms which do not pass technician review

结局指标

主要结局

Change in lexical decision making

时间窗: 10 minutes after TMS

Subjects will complete one computerized lexical decision making task before and after TMS stimulation in order to assess change in lexical decision making ability 10mins post stimulation. Subjects will see a word cue on the screen and asked to judge with a button press if the word cue is a "real word" or "not a real word."

Change in real-word reading efficiency

时间窗: 5 minutes after TMS

Subjects will complete a timed real word reading task before and after TMS stimulation in order to assess change in word reading ability 5mins post stimulation.; Subjects will read a list of words as quickly and as accurately as possible.

Change in Pseudoword reading efficiency

时间窗: 5 to 10 minutes after TMS

Subjects will complete a pseudoword reading task before and after TMS stimulation in order to assess change in pseudoword reading ability 5mins post stimulation. Subjects will read a list of pseudowords as quickly and as accurately as possible.

Change in phonemic decoding

时间窗: 5 to 10 minutes after TMS

Subjects will complete one computerized lexical phonemic decoding task before and after TMS stimulation in order to assess change in phonemic decoding ability 10mins post stimulation. Subjects will see a non-real word cue on the screen and be asked to judge with a button press if the non-real word cue can be pronounced like ("sounds like") a real word or not a real word.

次要结局

  • Change in function of neural reading network(20 minutes after TMS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

C. Nikki Arrington

Principal Investigator

Georgia State University

研究点 (2)

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