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临床试验/NCT03259568
NCT03259568终止不适用

Effects of rTMS on Human Brain Activity Measured With fMRI

Duke University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
2
主要终点
Activation of Cortical Networks During a Visual Motion Task.

研究概览

简要总结

This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on neural circuits as a function of spatiotemporal parameters and brain state in order to better understand why the method works and how to improve its efficacy. Leveraging our expertise in application of TMS methodology during concurrent single neuron recording techniques in non-human primates and imaging and scalp potential techniques in humans, the investigators aim to resolve three interlocking problems in the design and application of rTMS: stimulation frequency, spatial targeting, and interactions with brain state.

研究设计

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

盲法说明

Participant is not informed about TMS intensity.

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

  • Age between 18-
  • Use of effective method of birth control for women of childbearing capacity.
  • Willing to provide informed consent.

排除标准

  • Current or recent (within the past 6 months) of substance abuse or dependence, excluding nicotine and caffeine (urine test).
  • Current serious medical illness (self report).
  • History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator); [TMS Adult Safety Screening (TASS) form].
  • Subjects are unable or unwilling to give informed consent.
  • Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
  • Subjects with a clinically defined neurological disorder including, but not limited to:
  • Any condition likely to be associated with increased intracranial pressure
  • Space occupying brain lesion.
  • History of stroke.
  • Transient ischemic attack within two years.
  • Cerebral aneurysm.
  • Mini Mental Status Exam (MMSE) score of <
  • Parkinson's disease.
  • Huntington's disease.
  • i. Multiple sclerosis.
  • Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.
  • Subjects with cochlear implants
  • Subjects not willing to tolerate the confinement associated with being in the MRI scanner.
  • Women who are pregnant or breast-feeding (urine test).
  • Inability to read or understand English.

结局指标

主要结局

Activation of Cortical Networks During a Visual Motion Task.

时间窗: during each TMS session, up to 3 hours

Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal

Reaction Time

时间窗: during each TMS session, up to 3 hours

Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)

Motion Perception Accuracy

时间窗: during each TMS session, up to 3 hours

Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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