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临床试验/NCT01819675
NCT01819675终止不适用

Effect of rTMS Over Primary Motor Cortex on Gamma-aminobutyric Acid A (GABAA)-[18F]Flumazenil Binding: A Positron Emission Tomography (PET) Study

Seoul National University Bundang Hospital2 个研究点 分布在 2 个国家目标入组 6 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
2
主要终点
[18F]flumazenil binding potential

研究概览

简要总结

The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) over the brain can modulate the binding of neurotransmitter (GABA in this study) to its receptor using the special PET study.

详细描述

Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact mechanism is not well determined in human-beings. Changes in some neurotransmitters' status in brain after rTMS have been suggested as a possible mechanism, but role of GABA is not clear.

Twelve healthy people will be recruited. They will receive the rTMS over the primary motor cortex of the dominant hand. Individual subject will receive three sessions of rTMS with wash-out period (more than 3 days) between the rTMS sessions. Three rTMS sessions are high frequency (10Hz), low frequency (1Hz) and sham rTMS. The order of rTMS sessions will be randomly decided. After completing each rTMS session, [18F]flumazenil-PET will be checked.

The purpose of this study is to investigate 1)whether rTMS over the primary motor cortex can modulate the [18F]flumazenil binding potential and 2)whether the modulation of [18F]flumazenil binding potential by rTMS can be different according to the applied frequency of rTMS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • Healthy people
  • 18-50 yrs old
  • Right handedness
  • Written informed consent

排除标准

  • Previous medical diseases such as seizure, stroke, diabetes, hypertension.
  • Taking any drugs
  • Pregnancy
  • Contraindication of PET or MRI
  • Stroke or any tumor in MRI
  • Metals objects in the head or eyes
  • Cardiac pacemaker or cochlear implant

结局指标

主要结局

[18F]flumazenil binding potential

时间窗: up to 3 months

Immediately after rTMS session , PET image will be acquired. By using these images, \[18F\]flumazenil binding potential will be calculated in selected anatomical region up to 3 months

次要结局

  • Purdue pegboard test score(Before rTMS (baseline) and average 2hours after rTMS)

研究者

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

Nam-Jong Paik

Professor

Seoul National University Bundang Hospital

研究点 (2)

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