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临床试验/NCT06608680
NCT06608680招募中不适用

Timing and Facilitation Effects of Theta-Burst Stimulation in the Reading and Language Systems

Georgia State University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年4月5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
50
试验地点
2
主要终点
Phonological Decoding Reaction Time

研究概览

简要总结

The purpose of this study is to understand how transcranial magnetic stimulation affects how quickly, easily, and accurately a person read. Transcranial magnetic stimulation is a technique that uses magnetic fields to briefly affect how well certain brain regions function. The investigators would like to better understand how long the effects of transcranial magnetic stimulation occur in the reading system and at what point the effect is strongest in this system. The main questions it aims to answer are:

  1. At what point after stimulation are the greatest effects on behavior seen
  2. How excitatory and inhibitory stimulation affect behavior

Researchers will compare stimulation types against a sham condition to see effects on reading and language behavior.

Participants will be asked to

  • undergo reading, language, and cognitive testing
  • receive an MRI
  • receive TMS stimulation
  • perform language, reading, and motor tasks

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects must have a minimum of low average intellectual functioning (>=80) on at least one subscale on the Wechsler Abbreviated Scale of Intelligence-2 (WASI-2; Wechsler, 2011) to be included.
  • Within a normal range of reading skills as >85 on the Test of Word Reading Efficiency - Second Edition (TOWRE-2; Torgesen et al., 2012) and the Woodcock-Johnson IV Tests of Achievement (WJ-IV; Schrank et al., 2014)
  • Individuals with a documented history of learning disability will not be included. This will be determined via demographics questionnaire.
  • Subjects must be between the ages of 18 and 30 to be included. This will be determined via demographics questionnaire.
  • Because reading is critically linked to language, only individuals who are native speakers of English will be included in the study. This will be determined via demographics questionnaire.
  • The reading network is typically localized to the left side of the brain. However, left-handed individuals may have different brain lateralization, introducing an important confound to the study. Therefore, only right-handed individuals will be included in the study. This will be determined via demographics questionnaire.
  • Individuals who have hearing deficits (>25dB at 500+ Hz), visual deficits (>20/40), serious emotional problems, certain neurological conditions (e.g., uncontrolled seizure disorders) will not be included. This will be determined via CABI Screening Forms and Demographics Questionnaire.
  • Individuals with certain metals in their bodies or with certain health conditions will not be included. If an individual has braces on their 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 they will not be included. This will be determined via CABI Screening forms.
  • Individuals with MRI Screening and Contraindication Forms which do not pass MRI Tech review will not be included.
  • Individuals with TMS Screening Forms which do not pass TMS Tech review will not be included.

排除标准

  • 未提供

研究组 & 干预措施

iTBS/Sham

Experimental

Adults age 18-30 with typical reading and language abilities

干预措施: iTBS (Behavioral)

iTBS/Sham

Experimental

Adults age 18-30 with typical reading and language abilities

干预措施: Sham Stimulation (Behavioral)

cTBS/Sham

Experimental

Adults age 18-30 with typical reading and language abilities

干预措施: cTBS (Behavioral)

cTBS/Sham

Experimental

Adults age 18-30 with typical reading and language abilities

干预措施: Sham Stimulation (Behavioral)

结局指标

主要结局

Phonological Decoding Reaction Time

时间窗: Four time points after each stimulation (20, 40, 60 and 80 minutes after stimulation)

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

Rachael Marie Harrington

Assistant Professor

Georgia State University

研究点 (2)

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