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临床试验/NCT04586387
NCT04586387已完成不适用

The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy

Virginia Commonwealth University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年11月9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
入组人数
12
试验地点
1
主要终点
Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle

研究概览

简要总结

The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/

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
None

盲法说明

Participants will not be able to tell the difference if they are being given active vs sham stimulation but will receive both.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •nonimpaired individuals
  • •free of contraindications for MRI and TMS

排除标准

  • •musculoskeletal injury of the arm
  • •neurologic deficit affecting motor or sensory function
  • •concurrent severe medical illness
  • •diagnosis of SARS-CoV2, or symptoms consistent with COVID-19, or close contact with someone with SARS-CoV2 in the past 3 weeks

研究组 & 干预措施

Brain stimulation over bicep muscle than finger (FDI) muscle.

Experimental

Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups.

干预措施: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle (Device)

Brain stimulation over bicep muscle than finger (FDI) muscle.

Experimental

Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups.

干预措施: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle (Device)

Brain stimulation over than finger (FDI) muscle than bicep muscle.

Experimental

Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups.

干预措施: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle (Device)

Brain stimulation over than finger (FDI) muscle than bicep muscle.

Experimental

Brain stimulation will occur over two sessions. Both sessions will occur with sham stimulation then active stimulation. There will be a 3 day rest period between the two muscle groups.

干预措施: intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle (Device)

结局指标

主要结局

Change in Corticomotor Excitability With Sham Stimulation on Finger Muscle

时间窗: approximately 7 days

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Change in Corticomotor Excitability With Active Stimulation on Finger Muscle

时间窗: approximately 7 days

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Change in Corticomotor Excitability With Active Stimulation on Bicep Muscle

时间窗: approximately 7 days

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

Change in Corticomotor Excitability With Sham Stimulation on Bicep Muscle

时间窗: approximately 7 days

The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability

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 (1)

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