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临床试验/NCT02619643
NCT02619643已完成不适用

Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation

University of Minnesota0 个研究点目标入组 32 人开始时间: 2015年12月最近更新:
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
32
主要终点
Change from baseline resting motor threshold

研究概览

简要总结

Following brain injury (e.g. stroke), application of non-invasive brain stimulation may improve rehabilitative efforts. However, the most effective method of non-invasive brain stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus to the head. This method can be applied in a manner that increases (facilitates) or decreases (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions within minutes of each other (called primed PAS) may augment changes in excitability more than a single PAS session alone.

Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS) to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
Double (Participant, Investigator)

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

  • ≥ 18 and ≤ 30 years of age
  • Elicitable motor evoked potential from the motor cortex contralateral to the dominant hand
  • Elicitable N20 sensory evoked potential

排除标准

  • History of neurological disease
  • Seizure within the past 2 years
  • Currently taking epileptogenic medication
  • Peripheral neuropathy
  • Cognitive impairment and/or major psychiatric disorder
  • Metal in the head (dental permitted)
  • Pacemaker or other indwelling devices
  • Pregnancy

研究组 & 干预措施

Primed PAS 1A

Experimental

Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).

干预措施: Transcranial Magnetic Stimulation (Magstim) (Device)

Unprimed PAS 1B

Experimental

A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied.

干预措施: Transcranial Magnetic Stimulation (Magstim) (Device)

Sham PAS

Sham Comparator

A single session of sham paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied

干预措施: Transcranial Magnetic Stimulation (Magstim) (Device)

Primed PAS 2A

Experimental

Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).

干预措施: Transcranial Magnetic Stimulation (Magstim) (Device)

Unprimed PAS 2B

Experimental

A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied.

干预措施: Transcranial Magnetic Stimulation (Magstim) (Device)

Primed PAS 1C

Experimental

Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).

干预措施: Transcranial Magnetic Stimulation (Magstim) (Device)

Primed PAS 2C

Experimental

Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes).

干预措施: Transcranial Magnetic Stimulation (Magstim) (Device)

结局指标

主要结局

Change from baseline resting motor threshold

时间窗: Immediately before and within 60 minutes following intervention

Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The lowest stimulator output needed to elicit a consistent response will be recorded.

Change from baseline peak-to-peak amplitude of motor evoked potential

时间窗: Immediately before and within 60 minutes following intervention

Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The peak-to-peak amplitude of the EMG response will be measured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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