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临床试验/NCT04843137
NCT04843137撤回不适用

Investigating the Acute Effects of Transcutaneous Electrical Stimulation Parameters on Neural Circuits, Motoneuron Behavior and Motor Performance in Individuals With Cervical Spinal Cord Injury

University of Louisville1 个研究点 分布在 1 个国家开始时间: 2021年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Force control

研究概览

简要总结

The purpose of this study is to examine how delivery of subthreshold electrical stimulation of the spinal cord alters the excitability of neural pathways and consequently movement performance in healthy and spinal cord injured individuals. Specifically, we assess how stimulation parameters such as electrode configurations and stimulation frequency affect spinal excitability, corticospinal excitability, intracortical excitability, motor unit properties and force production. This study is not an intervention study, but a mechanistic study trying to shed light on how this novel neuromodulatory technique acutely affects the central nervous system.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cervical level injury (C5 to C7)
  • at least 1 year post-injury

排除标准

  • individuals with damage to the nervous system other than to the spinal cord
  • pregnant women (effects of stimulation on the fetus are unknown).
  • Transcranial magnetic stimulation-specific exclusion criteria:
  • participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
  • participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
  • participants with a history of seizures or epilepsy
  • participants taking any medication which may reduce seizure threshold

结局指标

主要结局

Force control

时间窗: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)

Force control during a variety of motor tasks is assessed during delivery of tcES. Comparisons are made between no stimulation and stimulation at different frequencies, or with different electrode configurations within each session. This assessment is repeated for different muscles on different days.

Motor evoked potentials recruitment curves

时间窗: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)

Motor evoked potentials are obtained to assess changes in the input/output properties of the corticospinal tract during delivery of tcES. Comparisons are made between no stimulation and stimulation at different frequencies, or with different electrode configurations. This assessment is repeated for different muscles on different days.

Intracortical excitability

时间窗: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)

Paired stimulation of the motor cortex is used to assess short interval intracortical inhibition intracortical facilitation during delivery of tcES. Comparisons are made between no stimulation and stimulation at different frequencies, or with different electrode configurations. This assessment is repeated for different muscles on different days.

Intramuscular coherence

时间窗: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)

High-density surface electromyography is used to decompose motor units and assess changes in intramuscular coherence during performance of a motor task in the presence of tcES. Comparisons are made between no stimulation and stimulation at different frequencies, or with different electrode configurations. This assessment is repeated for different muscles on different days.

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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