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临床试验/NCT06282406
NCT06282406
招募中
不适用

Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 110 人2024年6月3日

概览

阶段
不适用
干预措施
Transcutaneous Electrical Stimulation
疾病 / 适应症
Paresis
发起方
VA Office of Research and Development
入组人数
110
试验地点
2
主要终点
Force Control Change
状态
招募中
最后更新
8天前

概览

简要总结

Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which 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 modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning.

详细描述

Existing evidence supports the use of VNS to enhance the effects of traditional therapy on impairments due to neurological injury. It is known that the vagus nerve forms contacts with neuromodulatory nuclei in the brainstem that release of chemicals shown to be critically involved in attentional control and memory formation. It is also known that the auricular branch of the vagus nerve innervates portions of the external ear providing a possible means to engage similar neural pathways noninvasively via transcutaneous auricular vagus nerve stimulation (taVNS). Recent work from the PI's laboratory shows that electrical current applied to landmarks on the external ear elicits transient effects on pupil dilation, an established physiological index of brain states that support learning. Given the ability to engage the biomarker, the investigators aim to further investigate physiological mechanisms modulated by taVNS and possible effects on learning.

注册库
clinicaltrials.gov
开始日期
2024年6月3日
结束日期
2028年8月5日
最后更新
8天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • ALL PROSPECTIVE SUBJECTS:
  • 18-75 years of age
  • PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
  • Diagnosis of a single stroke resulting in hand impairment
  • Diagnosis of stroke at least six months prior to the time of participation

排除标准

  • ALL PROSPECTIVE SUBJECTS:
  • History of vestibular disorders or dizziness
  • Difficulty maintaining alertness and/or remaining still
  • Pregnant or expecting to become pregnant
  • Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
  • Ocular disease and/or impairment in more than one eye
  • History of seizure and/or epilepsy
  • Implants, devices, or foreign objects in the brain/body that are incompatible with MRI
  • Body size that is incompatible with MRI scanner dimensions
  • Anyone already enrolled and actively participating in another greater than minimal risk study.

研究组 & 干预措施

Paired, Sub-Threshold Stim

Sub-threshold stimulation paired with successful task repetitions

干预措施: Transcutaneous Electrical Stimulation

Paired, Supra-Threshold Stim

Supra-threshold stimulation paired with successful task repetition

干预措施: Transcutaneous Electrical Stimulation

Unpaired, Sub-Threshold Stim

Sub-threshold stimulation after successful task repetition

干预措施: Transcutaneous Electrical Stimulation

Unpaired, Supra-Threshold Stim

Supra-threshold stimulation after successful task repetition

干预措施: Transcutaneous Electrical Stimulation

Sham

No stimulation

干预措施: Sham

结局指标

主要结局

Force Control Change

时间窗: Pre, 1-week Post, 1-month Post

Subjects will be tested on the same task used for training that involves controlling finger forces.

研究点 (2)

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