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临床试验/NCT05316519
NCT05316519终止不适用

Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential

VA Pittsburgh Healthcare System1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年6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
终止
入组人数
4
试验地点
1
主要终点
Precision grip stability (coefficient of variation or root-mean-square error)

研究概览

简要总结

Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear activates neural pathways implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms that are modulated by auricular stimulation and its potential to enhance motor learning.

研究设计

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

盲法说明

Single-blind

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
是

入选标准

  • •(For prospective subjects diagnosed with stroke)
  • •Confirmed diagnosis of a single stroke at least six months prior to participation

排除标准

  • •History of vestibular disorders or dizziness
  • •Diagnosis of neurological disorders affecting movement
  • •Ocular disease and/or impairment in more than one eye
  • •Pregnant or expecting to become pregnant
  • •Difficulty maintaining alertness and/or remaining still

研究组 & 干预措施

Transcutaneous Vagus Nerve Stimulation

Experimental

Transcutaneous vagus nerve stimulation paired with visuomotor task training

干预措施: Transcutaneous Vagus Nerve Stimulation (Other)

Transcutaneous Stimulation (Sham)

Placebo Comparator

Transcutaneous stimulation paired with visuomotor task training

干预措施: Transcutaneous Vagus Nerve Stimulation (Other)

结局指标

主要结局

Precision grip stability (coefficient of variation or root-mean-square error)

时间窗: 1 month post training

The ability to stabilize precision grip according to target force and/or preload force will be quantified by calculating coefficient of variation (CV) or root-mean-square error (RMSE) which characterize variability in relation to mean force or target force.

次要结局

  • Force signal composition (Fourier transform)(1 month post training)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Michael A. Urbin

Scientist

VA Pittsburgh Healthcare System

研究点 (1)

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