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临床试验/NCT02919423
NCT02919423已完成不适用

TMS Modulation of Insula-related Brain Networks.02

Duke University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
2
主要终点
Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging

研究概览

简要总结

The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • generally healthy
  • between the ages of 18-55
  • right-handed

排除标准

  • significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion)
  • current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
  • meet DSM-5 criteria for current substance use disorder other than nicotine
  • use of psychoactive medications that would result in a positive urine drug screen
  • Current use of medications known to lower the seizure threshold
  • positive breath alcohol concentration
  • presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers)
  • among women, a positive urine pregnancy test
  • vision that cannot be corrected to 20/40

研究组 & 干预措施

10 Hz TMS

Active Comparator

active TMS will be administered

干预措施: transcranial magnetic stimulation (Device)

1 Hz TMS

Active Comparator

active TMS will be administered

干预措施: transcranial magnetic stimulation (Device)

结局指标

主要结局

Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging

时间窗: baseline and 1 week

Difference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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